cyrilzakka/clinical-trials huggingface dataset:
Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma

Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.

After completion of standard treatment, pts with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma were randomized to either observation or maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years. Both pts after first line therapy and pts after relapse treatment were included in the study. Pts with aggressive lymphoma were enrolled if they had achieved a complete response (CR) after initial treatment. Pts with aggressive lymphoma with residual tumor mass underwent positron emission tomography (PET) and qualified for randomization if this examination showed no signs of tumor activity. Pts with mantle cell lymphoma were eligible for the study if at least a partial response (PR) was achieved. Primary endpoint of the study was progression free survival (PFS), secondary endpoints were time to progression (TTP), overall survival (OS) and response to treatment. Differences between PFS and OS were analysed using the logrank test and the proportional hazard model of Cox. TTP was analyzed using a competing risk model with death as competing event.

Eligibility Criteria:
Inclusion Criteria:

* aggressive B-cell lymphoma or mantle cell lymphoma
* CR (complete remission) oder CRu (complete remission unconfirmed) after previous therapy
* PR (partial remission) only when PET is negative
* minimal age 18 years
* CD20+ expression on tumor cells
* effective contraception
* Karnofsky status \> 60
* written informed consent
Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C

Sepsis is a kind of disease with high morbidity and mortality in ICU. At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C have anti-inflammatory, antioxidant and immune-regulating effects. The purpose of this study was to investigate whether vitamin B6, vitamin B12 combined with vitamin C can improve the microcirculation and organ dysfunction in patients with sepsis, and improve the survival rate of patients with sepsis. The study included 296 patients who met the inclusion criteria. After randomization, the experimental group was given intravenous vitamin B6 300mg qd in addition to the basic treatment of sepsis Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. Control group 1 was given vitamin B6 300mg qd and vitamin B12 0.5mg q6h intravenously for 4 days. Control group 2 was injected with vitamin C 50mg/kg q6h intravenously for 4 days. Control group 3: The same dose of placebo (0.9% sodium chloride solution) was administered for 4 days. After medication, sublingual microcirculation image and radial artery resistance index of snus pit were detected and recorded according to the time required by the study protocol. The duration of use of pressor drugs, ventilator days, ICU stay, 28-day mortality, capillary refill time, changes in SOFA score and APACHEII score on day 3 and day 7 compared with baseline values at randomization, daily veno-arterial carbon dioxide differential pressure (GAP) and central venous oxygen saturation were recorded. After the end of the experiment, statistical analysis of the data was carried out to further explore the test results


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and \< 85 years old
2. Admitted to ICU
3. Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points

5. Obtain the informed consent of the subject or his family

Exclusion Criteria:

1. Patients have absolute contraindications such as vitamin allergy
2. Patients with a history of gout
3. Death is expected within 24 hours
4. Pregnant women
5. Use hydroprednisone or other equivalent dose hormones \> 200mg/d within 24 hours
6. Without the informed consent of the patient or his/her representative
7. Patients with a history of scleroderma
8. Patients with a history of vasculitis
9. Patients with oral mucosal diseases
10. Patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation
Combined Versus Successive Macular Hole and Cataract Surgery

The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.

Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).

Eligibility Criteria:
Inclusion Criteria:

* Macular Hole Stage 2,3,and 4
* Visual loss
* At least 18 years of age

Exclusion Criteria:

* Stage of Macular Hole Stage 1
* Macular hole post traumatism or associated with retinal detachment
* Diabetic retinopathy
* Glaucoma
* Age-related macular degeneration
* Myopia \> 6 diopters
* Preoperative pseudophakia
Characterization of Recently Deployed Veterans

This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Identical data will be collected on non-combat veterans that were seen in other primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005. This information will be used for comparison with the Iraqi veterans group. The data will be retrieved from a computerized list of these patients. Charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.

The information will also be used internally at the TVAMC to better define treatment needs and also used in presentations and possible publications at professional meetings and in journals.

While this study is designed to be hypothesis generating for large prospective studies, we hypothesize that a majority of the recently deployed veterans who served in the Iraq conflict are in need of basic primary health care needs for illnesses that are common place among patients within this age group, except for a higher than expected prevalence of mood and anxiety disorders compared to usual primary care treatment-seeking populations.

This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Identical data will be collected on non-combat veterans that were seen in other primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005. This information will be used for comparison with the Iraqi veterans group. The data will be retrieved from a computerized list of these patients. Charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, any race or ethic origin, at least 19 years of age
* Patients must have been seen by a provider in the outpatient Primary Care Clinic that has recently been set-up to serve recently deployed veterans who served during the Iraq conflict

Exclusion Criteria:

* Patients who did not serve during the Iraq conflict
Dose-effect Relationship Between microRNAs in Peripheral Blood and Radiation Injury

Rapid and accurate assessment of radiation injury dose is the key to success in early treatment and an urgent issue to be solved in clinical medicine.Researches showed that the expression of the microRNAs in human peripheral blood had much correlation with radiation injury resulted from different dosages of radiation.In this study,acute leukemic patients who will be pretreated by whole-body radiation are taked as the object of study,and biochip technology are adopted to detect the expression levels of the microRNAs in subject peripheral blood before-and-after radiation,and different expression is tested and Bioinformatics prediction,to evaluate the correlation between radiation injury dose and expression levels of the microRNAs in human peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

* subjects who suffer from acute leukemic subjects who accept chemotherapy within one month and will be pretreated by whole-body irradiation peripheral blood cells of subjects are approximate to those of healthy person aged between 18 and 50 years old subjects who are competent to give written informed consent subjects without other systemic diseases

Exclusion Criteria:

* subjects who suffer from serious other systemic diseases subjects who are unwilling or unable to cooperate with this clinical study other serious cases that probably hinder this clinical study
Low Dose Radiotherapy in COVID-19 Pneumonia

Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.

SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.

Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.

In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.

A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)
* Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
* Less than 3 days since the onset of ARDS
* Age \> 60 years
* ↑ IL-6 ( if available)
* ↑ CRP

Exclusion Criteria:

* Lack of informed consent
* Inability to transfer to the radiation unit
* Hemodynamic instability
* Septic shock and organ dysfunction
* Severe ARDS P/F ratio ≤ 100 mmHg
* History of cardiac failure
* Contraindications to radiation
Correlation Between Circulating Galactomannan and Beta-D-glucan and Clinical Outcome of Invasive Aspergillosis

The investigators hypothesize that early galactomannan and beta-D-glucan features, namely the height of the initial value at the time of diagnosis and the subsequent rate of marker decay within the first week(s) following therapy (day 7, day 14) are important factors in predicting clinical outcome.

A major challenge in the development of antifungal therapies for invasive fungal infections is the difficulty in assessing early treatment response and clinical prognosis. Mycological endpoints are often unreliable, reflected by the low sensitivity of fungal cultures to diagnose infection (20% for aspergillosis). Radiographic endpoints can be misleading, particularly when assessed early following treatment initiation. Clinical endpoints can be ambiguous indicators of treatment response, and generally include categorization of patient outcome as better, stable or worse. Furthermore, clinical assessments are likely confounded by the underlying diseases predisposing to fungal infection. Thus, a biomarker interposed between the initiation of antifungal therapy and patient outcome would bring much needed precision in the evaluation of novel antifungal drugs and thus serve as a valuable tool to guide decision-taking regarding ineffective treatments and dose selection in product development. The current absence of such biomarkers represents a critical capability gap. To date, only few studies have examined the prognostic value of fungal biomarkers in invasive aspergillosis on clinical outcome and have been limited by sample seize. To address this issue, the current study will examine the correlation between the fungal biomarkers galactomannan and beta-D-glucan with clinical outcome in invasive aspergillosis. The study will also incorporate C-reactive protein (CRP) levels, as they seem to be a useful surrogate marker of IL-6 production.

The investigator contains a sample database of 100+ patients with either probable or proven invasive aspergillosis for which daily marker levels and CRP (during the first two weeks of antifungal therapy) were measured and clinical assessment data at (2, 4 and ) 6 weeks post-treatment.

The study will evaluate whether serial serum measurements of galactomannan/beta-D-glucan during the first week(s) of antifungal therapy can distinguish between successful clinical outcome and failed clinical outcome at 6 weeks in patients with proven and probable invasive aspergillosis.

The study aims also at exploring various cut points for galactomannan/beta-D-glucan measurements at two weeks after initiation of antifungal therapy and at exploring the sensitivity and specificity for predicting clinical outcome at 6 and 12 weeks in patients with proven and probable invasive aspergillosis.

Eligibility Criteria:
Inclusion Criteria:

* proven or probable invasive aspergillosis with positive GM antigen test

Exclusion Criteria:

* Seronegative aspergillosis
The Safety and Efficacy of Administrating DiaPep277® Vaccination in Type 1 Diabetes Patients.

Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.

The objective of the study is to assess the efficacy and safety of administrating DiaPep277® in type 1 diabetes patients.


Eligibility Criteria:
Inclusion Criteria:

1. Fasting C-peptide levels \>= 0.2nmol/L.
2. Diagnosis of type 1 diabetes
3. No pregnancies or planned pregnancies of female subjects

Exclusion Criteria:

1. The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
2. The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
3. The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
4. Subject has history of endogenous allergic reactivity:

   * Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening-Ext Visit.
   * Ongoing systemic asthma treatment.
   * Subjects with history of life threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator's judgment.
5. The subject has known allergy to lipid emulsions.
6. The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
7. The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication that in the opinion of the Investigator might interfere with the study.
8. The subject has any of the following clinically significant laboratory abnormalities:

   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening-Ext Visit.
   * Total bilirubin greater than 1.3 times the ULN at the Screening-Ext Visit.
   * Subjects with severe renal failure at the Screening-Ext visit (as defined by glomerular filtration rate \< 30 mL/min/1.73 m2 by Cockroft und Gault calculation • Clinically significant laboratory abnormalities, confirmed by repeat measurement, which may interfere with the assessment of safety and / or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening-Ext Visit.
   * Fasting triglycerides \<1000 mg/dL (11.3 mmol/L) at the Screening-Ext Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
9. The subject is a known or suspected drug abuser.
10. The subject is known to test positive for HIV antibodies.
11. The subject has chronic hematologic disease.
12. The subject has liver disease such as cirrhosis or chronic active hepatitis.
Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients

The objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component.

The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual function.

Sexual function is an important aspect of quality of life. There is a link between heart disease and sexual dysfunction. Heart disease lowers the activity or the ability to perform the sexual activity. Sexual problems have a negative impact on quality of life and well-being, and sexual dysfunction is associated with anxiety and depression. The causes of sexual dysfunction are physical changes (the disease), mental changes and adverse reactions from medication. Despite the fact, that several international guidelines recommend that health professionals address sexual function in patients with heart disease, this is rarely done in practice. In Denmark there is no consensus or practice on how or where patients with heart disease and sexual dysfunction should be treated. Some patients are treated with phosphodiesterase type 5 inhibitors and a few referred to sexological clinics. Non-pharmacological rehabilitation interventions such as physical exercise, pelvic floor exercise, and sexual therapy have shown potential beneficial effect on sexual function. However, the effects have not been tested sufficiently, have not been tested in combination, and have never been tested in a Danish population.

Objective: The objective of this trial is to investigate the effect of a comprehensive sexual rehabilitation intervention program, consisting of a psycho-educative component and an exercise-training component plus treatment as usual versus treatment as usual in male patients with impaired sexual function and implantable cardioverter defibrillator or ischemic heart disease.

Design: CopenHeartSF is an investigator-initiated randomised clinical trial with blinded outcome assessment, including two university hospitals, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* Male patients above 18 years with sexual dysfunction associated with implantable cardioverter defibrillator or with ischemic heart disease verified by coronary angiography, which have a partner, speaks and understands Danish and provides a written informed consent

Exclusion Criteria:

* Patients at intermediate or high risk according to their cardiovascular status according to guidelines, with diseases in the urinary tract, who exercise intense more than 3 hours a week, patients with neurological or orthopedic deficits which prevent training, patients with cognitive deficits which prevents interviews, and patients who are included in ongoing research prohibiting additional research participation are excluded.
Gait Disorders in Patients With Cognitive Decline

The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools.

This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.

The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support.

These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 50
* Hospitalized patient in day hospital
* Patient with an etiological diagnosis of his cognitive disorder
* Patient having a neuropsychological assessment
* Patient able to walk without technical help
* Patient having agreed to participate in the study

Exclusion Criteria:

- Refusal to participate in the study
SCOSI-M: Preventing Prescription Drug Problems

Brandeis University and University of South Carolina (USC) have joined together to develop the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic detailing (medical education) intervention for physicians and evaluate its effectiveness in a pilot study. The goal of the intervention is to increase the use of safe prescribing and prescription monitoring practices among primary care physicians. The research team will design and pilot an educational intervention for physicians who treat military personnel, veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to prevent the onset or progression of prescription drug problems among Iraq and Afghanistan veterans, military members, and their families who are at high risk for developing problems if their treatment involves long-term use of an opioid.


Eligibility Criteria:
Inclusion Criteria:

1. a physician within one of the 3 practice environments;
2. typically prescribes Schedule II opioids to 10 or more non-cancer pain patients each month;
3. if community office-based, a substantial number of patients must have TRICARE (e.g., 20%); and d) willing to provide written consent for data collection and release of own SCRIPTS data.

Exclusion Criteria:

1. non-physician providers who report data to the SCRIPTS (dentist, veterinarians, nurses),
2. surgeons, pediatricians, or physicians predominately treating pain in cancer or surgical patients, and,
3. not eligible to register as authorized SCRIPTS user.