cyrilzakka/clinical-trials huggingface dataset:
Clinicopathological Characteristics of Colon Cancer in Young Age

A Study on the Characteristics of Colorectal Cancer by Age and sex.

The investigators aimed to investigate the prognosis according to sex and age by analyzing the clinical, pathophysiological, and molecular characteristics of colorectal cancer (CRC), and to find the factors influencing the prognosis of CRC.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated after being diagnosed with colorectal cancer

Exclusion Criteria:

* Patients under age of 18 years, or patients who cannot choose whether to participate or not
* Patients who refuse to participate in the study
The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS

To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

HIV-infected children are randomized to receive adjunctive therapy with intravenous methylprednisolone or placebo. Treatment is administered for 10 days. Primary antipneumocystis therapy with TMP/SMX or systemic pentamidine is selected by the individual investigator and given for 21 days. Patients are stratified at the time of randomization by the presence or absence of respiratory failure.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Recombinant erythropoietin and any FDA-approved cytokine for management of anemia.
* Antiretroviral agents.

Patients must have:

* Documented HIV infection.
* PCP.
* No more than 36 hours of prior primary therapy for confirmed or presumed PCP.

Prior Medication:

Allowed:

* Up to 35 hours of primary therapy for confirmed or presumed PCP.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Demonstrated intolerance to steroids.
* Requirement for steroids at greater than physiological doses for other medical conditions.
Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

Adenocarcinoma of the rectum

Stage II/stage III rectal cancer (if T4 only anal extension eligible)

Drug: UFT

Procedure: chemotherapy

Procedure: conventional surgery

Procedure: neoadjuvant therapy

Procedure: radiation therapy

Procedure: radiosensitization

Procedure: surgery

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive adenocarcinoma of the rectum , M0, lower side \< 10 cm from anal verge
* T3 or T4 disease (T4 exclusive anal extension )

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2 OR
* Zubrod 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin \< x2 UNL

Renal

* Creatinine \< 150 µMol/L

Gastrointestinal

* No history of inflammatory bowel disease
* No history of difficulty or inability to take or absorb oral medications

Neurologic

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
* No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No prior chemotherapy

Radiotherapy

* No prior radiotherapy to the pelvis

Other

* No other concurrent investigational drugs
* No other concurrent anticancer treatment
Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device

The purpose of this study is to calibrate the ViTrack™ arterial pressure waveform against intra-arterial pressure (IAP) in dynamic clinical settings and to assess the optimized ViTrack™ design to measure and continuously track blood pressure over a wide, clinically-relevant pressure range.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo noncardiac surgery with general or spinal anesthesia
* clinical indication for invasive intra-arterial pressure monitoring
* palpable pulse

Exclusion Criteria:

* difference of greater than 10 mmHg in the left versus right arm oscillometric systolic blood pressure
* Upper extremity arteriovenous hemodialysis shunt
* Upper extremity amputation
* Planned surgical position/draping that precludes access to the wrist
* Wrist distortion or pain from arthritis
* Prior trauma or surgery at the radial artery monitoring site
* Unable to provide informed consent
* Clinical contraindication as determined by the clinical team or study investigators
Plasma and Hemodynamic Markers During Hepatectomy

Introduction Liver resection is considered the only curative treatment option for mCRC patients without extrahepatic disease and is accepted practice. Despite substantial improvements in surgical techniques, postoperative morbidity and mortality remain an important concern after major resections. Complications of liver resection, although rare, include liver failure and acute kidney injury as indicated by oliguria and increased serum creatinine. The underlying pathophysiological pathways of post-operative renal alteration following liver resection is an increase in portal venous pressure, based on observations in animal models or small cohorts. The corpus of data is derived from patients with liver cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot distinguish between metabolic changes, portal hypertension and impaired liver function in the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent model to evaluate the impact of portal hypertension on the kidney despite stable liver function.

The most significant factor determining morbidity and mortality following hepatectomy is the ability of the remnant liver to regenerate. In this context, several growth factors were shown to regulate the highly orchestrated process of liver regeneration (LR).

Hypothesis The investigators will therefore test the hypothesis that liver resection leads to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal impairment, correlating with the quantity of resected liver.

Furthermore, the investigators will examine the relationship between postoperative liver regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based on the preclinical data the investigators hypothesize that a circulating growth factor levels will be associated with delayed liver regeneration, an increased incidence of postoperative liver dysfunction and concomitant worse clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patient with neoplastic liver tumors undergoing elective hepatectomy.

Exclusion Criteria:

* Non elective hepatic surgery, preoperative HVPG \> 10 mmHG, preoperative renal failure
SAMBA EU Femoropopliteal Trial

The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.


Eligibility Criteria:
Inclusion Criteria:

Screening

1. Patient must be ≥ 21 years of age with life expectancy \> 1 year.
2. Symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (Rutherford category 2-4; claudication, rest pain).
3. Patient must be a suitable candidate for PTA and stenting.
4. Patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements.
5. The patient or legal representative has provided written informed consent using a form that is reviewed and approved by the EC for the Clinical Site.

Pre-Intervention

1. Target lesion has ≥ 50% stenosis as demonstrated angiographically.
2. Lesion length ≤ 15 cm.
3. Reference vessel diameter of 5 to 6 mm.
4. Patient has at least 1 vessel run-off prior to treatment.

Exclusion Criteria:

Screening

1. The subject is pregnant or will become pregnant during the study or has any other condition that would preclude having x-rays. (Pre-menopausal women must have a negative pregnancy test within 7 days of the procedure.)
2. Patients who have experienced a cardiovascular accident (CVA) or a myocardial infarction (MI) within 3 months prior to the procedure.
3. Subject has had or plans to have a surgical or interventional procedure within 30 days before or after the implantation procedure of the SAMBA Stent.
4. Existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy.
5. Contrast allergy that cannot be corrected with medication (e.g. steroids, etc.).
6. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
7. Patient is currently participating in another investigational drug or device study.

Pre-Intervention

1. Uncorrectable severe aorto-iliac occlusive disease or severe common femoral artery stenosis preventing access or limiting inflow (e.g., stenosis greater than 50%).
2. Uncorrectable occlusive disease limiting outflow (e.g., stenosis greater than 50%)
3. Patients with previous surgery in the target vessel or stent that will be closer than 2 cm to either edge of SAMBA Stent(s).
4. Lack of 1 cm of healthy vessel proximal to proximal target
5. Lack of popliteal reconstitution (at least 2 cm of normal distal popliteal).
6. Inability to cross the lesion with a guidewire.
7. More than 1 lesion in the same limb requiring treatment that will not be covered by continuous stenting.
8. Unsuccessful balloon pre-dilation (i.e., the residual stenosis is greater than 30%).
CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)

To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.


Eligibility Criteria:
Inclusion Criteria:

1. Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed
2. Male or female 18 years of age or older
3. Chronic hepatitis C infection based on history of positive serum anti-HCV antibody and/or HCV RNA
4. Patients must have documented failure to respond to past treatment with PEG-Intron or Pegasys plus RBV.
5. Liver biopsy within 3 years of screening documenting chronic liver disease consistent with chronic hepatitis C

Exclusion Criteria:

1. Patients with any history of decompensated liver disease including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy
2. Specific laboratory abnormalities at Screening
3. Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin treatment, but who relapsed during follow-up
4. Recent depression or psychiatric disorders
5. Known HIV infection or positive HIV antibody test at Screening
6. Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at Screening
7. Unstable or uncontrolled thyroid disease
8. Presence or history of non-HCV chronic liver disease
9. History of unstable or deteriorating cardiovascular or cerebrovascular disease within 6 months prior to Screening
10. Current or history of neurologic disorder within a specified time frame
11. A disease known to cause significant alteration in immunologic function including hematological malignancy, sarcoidosis or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, leukemia, lymphoma, autoimmune thyroid disease, scleroderma, psoriasis, inflammatory bowel disease, multiple sclerosis etc.)
12. History of major organ transplantation (i.e., liver, kidney, lung, or heart) with an existing functional graft, including bone marrow transplant or stem cell transplant
13. Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as cyclosporine, azathioprine, chronic systemic corticosteroids, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
14. Pregnant or lactating women
15. Liver biopsy within the past three years documenting cirrhosis
Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour

This is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the Inflammation Based Index (IBI) score as a marker for predicting clinical and radiological response in patients treated with Lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors.

This IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows:

* IBI = 0: Low mortality risk (if CRP and serum albumin values are considered normal in the investigator's judgment).
* IBI \> 0, including: IBI = 1: Intermediate risk of mortality (if one of the two values is considered abnormal and clinically significant according to the investigator's judgment (either hypoalbuminemia or elevated CRP)); IBI = 2: High mortality risk (if both values are considered abnormal and clinically significant according to the investigator's judgment (hypoalbuminemia and elevated CRP)).

Patients were followed up for 36 months.

A total of 150 patients should be included in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged ≥ 18 years.
2. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.
3. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization.
4. Evidence of progression in the 12 months preceding Lu-177oxodotreotide therapy, confirmed by imaging techniques commonly used in current practice (thoraco-abdomino-pelvic CT and/or liver MRI, Ga-68 DOTA somatostatin analog PET-CT) +/- liver involvement greater than 50%.
5. Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI.
6. Patient affiliated to a social security scheme in France.
7. Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.

Exclusion Criteria:

1. Previous treatment with Lu-177 oxodotreotide.
2. Any contraindication to treatment with Lu-177 oxodotreotide.
3. Morbid obesity (BMI \> 40).
4. Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.
5. Active carcinoid heart disease or other acute cardiovascular event.
6. Active infection not treated within 15 days.
7. Pregnant or breast-feeding woman.
8. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
9. Patient deprived of liberty or under legal protection (guardianship, legal protection).
Antipsychotic Polypharmacy: Prevalence, Background and Consequences

The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors.

Several surveys have shown a high prevalence of antipsychotic polypharmacy (concomitant prescription of at least 2 different antipsychotics) among patients with schizophrenia even though international guidelines recommend monotherapy.

From register data areas with differences in the prevalence of antipsychotic polypharmacy will be identified. Two high prevalence areas will be randomized to either control or intervention area. In the intervention area an intensive educational intervention consisting of outreach visits with a multifaceted approach will be carried out with the duration of 1 year.

Differences in health staff related factors such as knowledge and attitude towards clinical guidelines will be assessed with a questionnaire before and after the intervention in the intervention area as well as in the low prevalence area at baseline.

Medical records data describing the use of antipsychotic polypharmacy will be collected. With register data health economic issues will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* The intervention is not aimed directly to the patients but their health care providers.
* Patients with schizophrenia (F2\* diagnosis according to ICD-10) taking antipsychotic medication and their health care providers in the specified areas will enter the study:
* The patients will enter with data from their medical record, register data and a few exploring interviews while the health staff will enter with their questionnaire data.
Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT

Increasing radiation exposure by medical examinations is getting more concerns. For optimal medical imaging, reducing radiation exposure with preservation image quality is important. One of the solutions is use of iterative recontruction of CT examination. In this study, the investigators aimed to investigate the clinical feasibility of ultralow dose abdominopelvic CT with iterative reconstruction in patients with intraabdominal abscess. Patients with intrabdominal abscess usually undergo multiple CT examinations to evaluate treatment response. Therefore, ultralow dose CT can reduce unnecessary radiation exposure in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. patients who underwent standard dose CT for suspected intraabdominal abscess
2. patients who need follow-up CT to evaluate treatment response of abscess 3) Adult patient, 4) patients who agreed this study protocol

Exclusion Criteria:

1. pregnancy
2. patients with poor renal function (GFR \< 30 mL/min/1/73m2)
3. Patients who have allergy to CT contrast media
4. Patients who are not cooperative (e.g., dementia)
Evaluation of the Efficacy of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Unilateral Neglect in Patients With Subacute-Chronic Phase After Ischemic Stroke

The aim of this study was to randomize stroke patients with unilateral neglect into 2 groups, active and sham groups, and to examine the effects of active inhibitory repetitive transcranial magnetic stimulation on the reduction of neglect symptoms, functional recovery and independence of these patients in activities of daily living.

Patients diagnosed with ischemic stroke at least 1 month ago, with unilateral neglect, receiving inpatient rehabilitation at stroke clinics, and meeting the study criteria for both genders between the ages of 18-80, will be divided into two groups. A total of 22 stroke patients, informed about the applied treatments and potential risks, and providing written consent, will be randomly assigned to receive either active repetitive transcranial magnetic stimulation (rTMS) combined with conventional rehabilitation (Mirror therapy and Visual scanning training) or sham (imitation) repetitive transcranial magnetic stimulation (rTMS) combined with conventional rehabilitation.

The study will include 22 randomly selected patients with neglect, with 11 planned in the intervention group and 11 in the control group. Patients will receive active rTMS or sham rTMS for a total of 10 sessions, each lasting 20 minutes, alongside conventional rehabilitation over a period of 2 weeks. rTMS applications will be conducted once daily before the daily rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* First-time ischemic stroke
* Patients at least 1 month after the stroke
* To be aged between 18 and 80 years old
* Presence of unilateral neglect
* No significant cognitive impairment (MMSE \> 24 points)
* Signing an informed consent form indicating willingness to participate in the study

Exclusion Criteria:

* Epilepsy, history of seizure
* Metallic implant in the area of stimulation (cochlear implant, brain pacemaker, drug pump etc.)
* Presence of cardiac pacemaker
* Severe general condition disorder or accompanying neurological disease
* Aphasi
* Pregnancy
* Under 18 years of age and over 80 years of age
* Visual impairment
Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy

Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients with creatinine clearance \< 60 mL/min

Exclusion Criteria:

* contrast medium administration within the previous 10 days
* end-stage renal failure requiring dialysis
* refusal to give informed consent