cyrilzakka/clinical-trials huggingface dataset:
Bendamustine Plus Rituximab for Mantle Cell Lymphoma: a Multicenter Retrospective Analysis(BR-MCL)

This study with retrospective data collection does not entail sample size calculation. The study will involve patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma and meet the inclusion/exclusion criteria at each participating study site. Considering the incidence of mantle cell lymphoma in Korea and the number of participating sites, the expected sample size is approximately 40.

1. Inclusion criteria : Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification) 1) mantle cell lymphoma 2) leukemic non-nodal mantle cell lymphoma 3) in situ mantle cell neoplasia
2. Age ≥ 19 years
3. Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included.

2. Exclusion criteria :

1. Patients whose clinical and pathological data are not available
2. Patients who were not treated with a combination of bendamustine and rituximab

Data of patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma collected before the date of first submission of an IRB application for new project will be analyzed.

The aim is to publish the data analysis and study results before December 2020. The expected overall study period is until December 2020.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification)

  1. mantle cell lymphoma
  2. leukemic non-nodal mantle cell lymphoma
  3. in situ mantle cell neoplasia 2. Age ≥ 19 years 3. Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included.

Exclusion Criteria:

* 1. Patients whose clinical and pathological data are not available 2. Patients who were not treated with a combination of bendamustine and rituximab
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.


Eligibility Criteria:
Please contact site for information.
Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients

Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized
* one or more positive blood cultures for Candida spp,
* positive beta-glucanemia
* the presence of at least one clinical symptom of infection will be considered cases of candidemia.

Exclusion Criteria:

* age less than 18 years
* state of immunosuppression
* incompleteness of clinical data
* unavailability of serum samples in sufficient quantities for analysis and in good condition.
Thrombolysis in Ischemic Spinal Cord Stroke

Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%.

Ischemic stroke of the spinal cord can arise from:

1. Dissection of the aorta.
2. Aneurism in the aorta.
3. Atherosclerotic disease of the aorta or vertebral arteries.
4. Spinal surgeries.
5. Spinal AVM.
6. Embolism from cardiac origin.
7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. In most cases the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense.

The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS). Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the spinal cord is necessary upon arrival in the emergency department.

One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with vascular risk factors
2. Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
3. Window treatment - not over 6 hours since the start of the event till the start of the treatment.
4. Patient without dissection of the aorta in the abdomen.
5. Patient without contraindication to IVtPA.
6. Patient with no etiology found after clarification.

Exclusion Criteria:

1. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with contraindication IVtPA.

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A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers

This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2 crossover method.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases
Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients

With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation after successful catheter ablation procedure among patients with atrial fibrillation and obstructive sleep apnea. The results from this study will help us refine the design for a future larger study, and will ultimately improve care of patients with obstructive sleep apnea and atrial fibrillation.

Obstructive sleep apnea, a sleep-related breathing disorder in which breathing stops for short periods during sleep, is a common condition in patients with atrial fibrillation. Studies have shown that up to 75% of atrial fibrillation patients undergoing catheter ablation procedure have obstructive sleep apnea. Obstructive sleep apnea increases the risk of atrial fibrillation recurrence after successful catheter ablation by 40%. However, whether treatment of obstructive sleep apnea with positive airway pressure (PAP, the current most effective treatment for obstructive sleep apnea that uses a machine to help breathe more easily) reduces the risk of atrial fibrillation recurrence is not fully understood. The purpose of this study, therefore, is to examine whether positive airway pressure therapy reduces atrial fibrillation recurrence after catheter ablation in patients with obstructive sleep apnea and atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18 years or older
2. First-time catheter ablation for atrial fibrillation
3. Moderate-to-severe obstructive sleep apnea diagnosed with a sleep study (apnea-hypopnea index ≥ 15)

Exclusion Criteria:

1. Current or prior use of positive airway pressure for obstructive sleep apnea
2. Any household member with current/past positive airway pressure use
3. Did not meet minimal adherence to positive airway pressure treatment (≥ 4 hours/night and ≥ 70% of time in 2 weeks)
4. History of motor vehicle or occupational accident related to excessive sleepiness
5. Severe nocturnal desaturation documented on sleep study as \>10% of total sleep time with oxygen saturation of \< 75%
6. Any condition determined by physicians that constrains the use of positive airway pressure such as anatomically fixed nasal obstruction, neurological impairment, and significant claustrophobia.
7. Congestive heart failure (New York Heart Association IV)
8. Severe valvular disease
9. Planned coronary revascularization procedure in the next 6 months
10. Severe pulmonary disease
11. Participation in another treatment intervention trial that might influence results of this trial
12. Ablation procedure scheduled in the next 8 weeks
Improving Sleep to Reduce Risk for Substance Use Disorder

Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance prospectively predicts the development of SUD and may confer risk for SUD by increasing stress reactivity, decreasing decision-making abilities, and ultimately promoting substance use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge, no experimental studies have determined whether improving sleep leads to reductions in SUD risk. As such, the current study will use a randomized controlled trial design to test the effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms through improvements in sleep. Furthermore, we will test direct and indirect effects of condition on theoretically proposed mechanisms underlying the association between sleep disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).


Eligibility Criteria:
Inclusion Criteria:

* Trauma exposure
* Current cannabis use
* Insomnia symptoms
* Age 18-30

Exclusion Criteria:

* Severe substance use disorder
* Receiving treatment related to sleep or substance use
Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers

The aim of this study is to determine if oxytocin administration is able to blunt LPS induced increase of cytokines (TNF-α) and if there is a change in the endocrine response after lipopolysaccharide administration in humans.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years or older with no disease history
* Written informed consent

Exclusion Criteria:

* Receiving any medication
* Probands who suffer from infectious disease
Microbiological Profile of VAP Patients in Respiratory ICU

Identification of the microbial profile of Ventilator associated pneumonia causing microorganisms among Respiratory ICU patients .

Ventilator-associated pneumonia (VAP) is one of the common serious infectious diseases encountered in the intensive care unit (ICU), which highly affects the healthcare cost and patient prognosis.

All-cause of mortality associated with VAP has been reported to range from 20% to 50%.

The etiology of VAP and their antimicrobial susceptibility pattern varies with different patient populations and types of ICUs.

VAP may be caused by a wide spectrum of bacterial pathogens, which may be polymicrobial and are rarely due to viral or fungal pathogens in immune-competent hosts.

Common etiologic agents are Gram-negative bacilli such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter spp. and Staphylococcus aureus among Gram-positive cocci.

Due to the increased incidence of MDR organisms in Intensive Care Units (ICUs), early and correct diagnosis of VAP is mandatory for optimal antibiotic therapy. The frequency of specific MDR pathogens causing VAP varies in hospitals, patient populations. Also varies according underlying disease.

this study will be conducted in respiratory intensive care unit, chest disease and tuberculosis department at Assiut university hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.
2. Age \> 18 years.

Exclusion Criteria:

1. Patients with clinical and radiological signs suggestive of pneumonia before intubation (community acquired pneumonia or hospital acquired pneumonia)
2. Patients age ≤18 years old
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Agreed to avoid disallowed meds

Exclusion Criteria:

* Known hypersensitivity to hyaluronidase and/or bee sting
* Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
* Atopic individuals assessed by medical history
* Topical/inhaled/systemic corticosteroids within 30 days
* Concurrent use of antihistamines or anti-inflammatory during study
* Active or chronic disease likely to affect immune function
* History of alcohol/drug abuse within 6 months
Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.

Observational study of 500 recruited and 300 evaluable patients with de novo large cell B Cell lymphoma, age 18-80. Standard guideline recommended treatment by treating physicians discretion. Collection of clinical data, PET-CT data, liquid biopsy, WGSequencing to determine optimal prognostic factors to surpass prediction offered by current IPI.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of DLBCL\&LBCL
2. Planned treatment with guideline-based first-line therapy
3. Patient's consent
4. All genders, Patient age ≥ 18 years
5. Ability to consent

Exclusion Criteria:

1. Treatment with R-CHOP/-like regimens already started
2. Relationship of dependence/ direct employment with the investigator
3. Active HIV-infection
4. Presence history of other active cancers (with the exception of basal cell carcinoma of the skin)
Potential Health Effects of Aronia Intake

Intervention cross-over study during which participants receive standardized amounts of aronia berry tablets or placebo for three months, then wash out for three months, then aronia tablets or placebo for three months. The potential health effects are investigated. Following parameters are measured before and after each period of tablet intake: 1) Blood pressure, 2) Lipid fractions, 3) Testosterone, 4) Phase II markers, 5) HbA1c, 6) HSCRP, 7) F2-isoprostanes, and 8) semen quality.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men with total cholesterol between 5 and 7 mmol/L, who do not take medication

Exclusion Criteria:

* Chronic diseases and intake of medication or antioxidants
Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

Abstract

Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes.

Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.


Eligibility Criteria:
Inclusion Criteria:

* In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study.

Exclusion Criteria:

* Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study.
* Patients with unbalanced endocrine disease or any disease that might affect absorption of medications.
* Patients with plasma creatinine \> 1.5 mg/dl, and electrolyte abnormalities.
S-ADHF：Sarcopenia in Patients With ADHF

This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.

Guangdong Provincial People's Hospital will be the lead center, with an additional 4 hospitals designated as satellite centers for the study. Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minimum of of 195 cases each for patients with and without sarcopenia The sympathetic nervous activity, psychosocial factors, quality of life, physical function and baseline physical activity will also be observed and recorded at baseline. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death. The primary clinical outcome is all-cause mortality at 6 months. Other clinical outcomes of interest include cardiovascular mortality, all-cause hospitalisation, HF hospitalisation, the frequency and length of hospitalization of patient readmitted and survival time from enrollment to death of deceased patients.

This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. S-ADHF will provide important information and evidence on the clinical aspects of sarcopenia in patients with ADHF, and will potentially and contribute to accurate risk stratification and optimal clinical management for patient with ADHF.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
3. At least two of the signs of heart failure (HF):

Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.

Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).

Peripheral edema. Elevated B-type natriuretic peptide (\>100 pg/ml) or elevated N-Terminal Pro-Brain Natriuretic Peptide (\>300 pg/ml).

Willingness to provide informed consent and cooperate with the follow-up

Exclusion Criteria:

1. Unable to understand and comply with protocol or to give informed consent
2. End-stage diseases other than heart failure, life expectancy \<1 year, such as malignant tumors
3. Current or planned participation in a clinical trial.
Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy

Isolated and combined effectiveness of pragmatic protocols on shoulder range of motion had been investigated and found effective in healthy participants. To our knowledge, there was insufficient literature to support the comparison between pragmatic and traditional protocols in the treatment of shoulder pathologies.

Different physical therapy treatments are being used for shoulder pathologies which include modalities (hot pack, TENS), ROM exercises, stretching, strengthening, soft tissue mobilization and set of pragmatic manual techniques.The set of pragmatic manual therapies are novel techniques (comprises of acromioclavicular mobilization, serratus anterior stretch, thoracic manipulation, RC facilitation, and PCS) and its isolated effectiveness on ROM in healthy subjects has been investigated and found effective. These studies recommended the use of a pragmatic protocol for the prevention and rehabilitation of shoulder injuries and pathologies (unpublished data).As per our knowledge there is insufficient literature to support the comparison of the effectiveness of a set of pragmatic protocols with traditional interventions. Our research is proposed to compare the efficacy of pragmatic interventions with that of traditional interventions in patients with shoulder pathology and their effect on the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Functional movement score 1 and 2 or limitation in Range of motion of Abduction, internal rotation, external rotation, RUBB, and RDBN. All or only one of the limitations in comparison with the unaffected shoulder joint.

Exclusion Criteria:

* Patients with shoulder instability. Functional movement score 3 and 0. Individuals with recent fractures of fewer than 6 weeks duration. Cancerous Growth around the shoulder girdle. Breast cancer and undergoing chemotherapy and radiotherapy. RA arthritis patients. Long-term use of steroids and severe osteoporosis.