cyrilzakka/clinical-trials huggingface dataset:
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath

This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. In both arms, treatment is continued in case of response for up to two months.


Eligibility Criteria:
Inclusion Criteria:

Both Arms:

* T-ALL or T-lymphoblastic lymphoma
* CD52-expression \> 20%
* Aged \>= 18 years
* ECOG/World Health Organization (WHO) performance status 0-2
* Life expectancy of \> 2 months
* Contraception during, and for at least 6 months after, therapy
* At least a 2 week interval to the last cycle of chemotherapy (decision in individual cases if rapid progression)
* No persistent toxicity from earlier cycles
* Written informed consent

Arm 1:

* Evidence of MRD \> 10(-4) with confirmation beyond week 16 in the GMALL-Study 07/2003

Arm 2:

* Relapse with failure to at least one salvage therapy or primary failure after induction therapy and at least one salvage therapy

Exclusion Criteria:

* Substantial restrictions of heart, lung, liver, or kidney function
* Active infection, HIV seropositivity or cytomegalovirus (CMV) viraemia
* Pretreatment with MabCampath®
* Known anaphylaxis to humanised antibodies
* Permanent systemic therapy with corticosteroids
* Central nervous system (CNS) involvement
* Extramedullary bulky disease
* Active secondary malignancies
* Pregnancy or nursing
* Mental disease or circumstances that prohibit compliance with the protocol procedures
Nattokinase Supplementation and Hemostatic Factors

The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 69 years
* Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
* Nondiabetic (fasting blood glucose \< 126mg/dL and 2-hour blood glucose \< 200mg/dL)

Exclusion Criteria:

* Use of any medication or supplements
* Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment
* Women who were pregnant, breastfeeding or intending to become pregnant during the study period
* Drug or alcohol abuse
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent period (=the time period between the time the water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the mother and infant.

Preterm premature rupture of membranes (PPROM) complicates 2-3.5% of pregnancies and precipitates labor in 30-40% of preterm deliveries. The common practice in early PPROM with no evidence of chorioamnionitis is admission for close surveillance, antibiotic treatment and steroids for fetal lung maturation (until 32 weeks gestation. Intraamniotic infection is evident in up to 75% of women who develop labor during admission. The infection is for the most an ascending infection.

Cranberries have been recognized by the American Indians as a natural means for preventing urinary tract infection. The mechanism of action includes acidification of urine and inhibition of adhesion of pili-harboring bacteria to the transitional epithelium of the urinary tract.

We assume that cranberries will lower the rate of maternal urinary tract infection. Moreover, the active ingredients will pass transplacentally to the fetus, will be secreted in its urine hence, in the amniotic fluid. The active substances would coat the vagina and bring about their effect also in that environment. Having in mind that most if not all chorioamnionitis infections are caused by ascending infection, the cranberries might lengthen the latent period and reduce infectious maternal and neonatal morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Proven premature rupture of membranes
* less than 35 weeks of gestation with good obstetrical dating
* no suspicion of amnionitis
* signed informed consent

Exclusion Criteria:

* Known sensitivity / allergy to cranberries
* Women treated with warfarin
* Drug intolerance
A Study to Compare Caries Detection in the Pediatric Population Between the iTero Element 5D System and Bitewing Radiographs

This is a non-significant risk, single site, prospective clinical study. The study will be conducted in the department of pediatric dentistry of the faculty of dental medicine of the Hebrew university, Israel

This is a non-significant risk, single site, prospective study to be conducted in the department of pediatric dentistry of the Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel. Subject participation will require one visit during which consent, screening, enrollment, and imaging will be performed.

Clinical and diagnostic methods to be used during this study are those that are routinely used in the diagnosis of caries in this site, which include bitewing radiographs (BWR). This standard of care is provided for all site's patients, including the patients who don't participate in this clinical study.

A standard set of BWR for subjects ages 4-9 years will be taken to include the complete dentition of the subjects. No additional x-ray should be taken for the sole purpose of this trial.

In addition to the routine clinical diagnostics, the subjects will be scanned using the 5D system. The investigator will capture a full arch scan of the maxillary arch and mandibular arch of each subject with the iTero Element 5D system. For each subject, the Investigator will grade carious lesions in the BWR and Element intra-oral scan according to ADA staging guidelines. The results will be documented using Caries Evaluation Forms. The Investigator will assess and document the findings of each diagnostic test separately before reviewing the next test.

In cases where caries debridement is indicated, carious lesion depth will be documented during and compared to NIRI and BWR images.

All treatment decisions will be made according to the standard of care in the clinic and no treatment will be conducted for the sole purpose of the study

Eligibility Criteria:
Inclusion Criteria:

* Ages 4-9 years
* Subjects scheduled for bilateral BWR as part of their standard of care
* Subjects with a recent bilateral BWR which were obtained up to 14 days prior to study visit

Exclusion Criteria:

* Subjects who have been diagnosed with epilepsy
* Subjects with a known allergy to latex or plastic
* Subjects with allergies to any dental or oral health products
* Subjects who have undergone a dental treatment since the acquisition of the recent bilateral BWR
Promoting Neuroplastic Changes of Patients With TBI

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and/or potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.

Eligibility Criteria:
Inclusion Criteria:

* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
* Hemiplegia or hemiparesis
* 0≤Manual Muscle Testing (MMT)\<=2
* Age 30-85
* Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

Exclusion Criteria:

* Medically not stable
* Associated acute medical illness that interferes with ability to training and exercise
* No impairment or very mild ankle impairment of ankle
* Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
* Cognitive impairment or aphasia with inability to follow instructions
* Severe pain in legs
* Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
* Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee
Benefits of CTO-PCI in Selected Cases With HFrEF (CTOHFrEF)

The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.

Observational studies have shown that chronic total coronary occlusion percutaneous intervention (CTO-PCI) improves angina, left ventricular ejection fraction (LVEF), and survival. None of these studies aimed to assess the benefits in populations with heart failure with reduced ejection fraction (HFrEF). The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.

Using cardiac magnetic resonance (CMR), the investigators studied 29 patients with HFrEF and evidence of viability and/or ischemia in the territory supplied by an occluded vessel who were successfully treated with CTO-PCI. Non-CTO PCI was also performed in patients with multi-vessel disease, . Imaging parameters, clinical status, and brain natriuretic peptide (BNP) levels were evaluated before and six months after CTO-PCI.

Eligibility Criteria:
Inclusion Criteria:

* At least one chronic total coronary occlusion
* LVEF ≤40% by CMR
* Evidence of myocardial viability and/or ischemia in at least two contiguous segments subtended by the occluded vessel.

Exclusion Criteria:

* Women of childbearing age or pregnant
* Claustrophobia
* Admission to hospital within the previous 90 days due to decompensated heart failure, myocardial infarction or unstable angina.
* Severe valvulopathy
* Pacemaker or implantable cardioverter defibrillator
* Indication for coronary artery bypass surgery
* Heart transplantation waiting list
* Follow-up not feasible
* Life expectancy shorter than 12 months.
* Iodine contrast or gadolinium allergy
* Aspirin or clopidogrel allergy
* Asthma
* NYHA IV class
* Liver cirrosis
* Noncompliance with medical treatment
* Chronic kidney disease with serum creatinine levels ≥ 2.5 mg/dl or glomerular filtration rate ≤30 ml/min/1.73m2
* Evidence of active bleeding
* High risk of bleeding
* CTO distal vessel not visible through collateral circulation
* CTO distal vessel diameter \<2mm
* Absence of acceptable vascular access
19F Thoracic Radiotherapy for Lung Cancer

The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR functional lung imaging into the routine assessment of lung cancer patients prior to thoracic radiotherapy.

Primary Objective:

Determine feasibility by evaluating if:

PO1: Patients diagnosed with lung cancer are able to successfully complete pre- and post-radiotherapy 19F MR imaging scans as scheduled.

Secondary Objective:

Determine efficiency by evaluating if:

SO1: Determine efficiency by evaluating if 19F MRI data can be successfully analyzed and incorporated into the radiation planning system.

SO2: Determine efficiency by evaluating if the incorporated 19F MRI functional data can be successfully used to generate radiotherapy plan in a timely manner.

SO3: Determine if pre- and post radiotherapy 19F MRI scans can be readily compared to observe changes in pulmonary function.

Hypotheses Investigators hypothesize that functional 19F MR imaging assessment is feasible in the lung cancer patient population and that the acquired images can be efficiently analyzed and integrated into radiotherapy planning.

Eligibility Criteria:
Inclusion Criteria:

* Subject has histologic or cytologic confirmation of lung cancer (NSCLC or Small cell) and has been recommended thoracic radiotherapy as part of standard of care management.
* Ability to undergo MR imaging, tolerate breath hold procedures and follow direction during the imaging process
* Karnofsky performance status ≥60, with expected survival of ≥6 months
* At least 18 years of age
* Patient is not pregnant
* Patient can be reliably reached for post-MRI follow up AE check.
* Patient able to sign a study specific informed consent form.

Exclusion Criteria:

* Any condition including, metallic implants or cardiac pacemakers that makes the candidate ineligible for MR imaging. (MRI research screening form will be completed prior to each MRI scan).
* Malignant pleural effusion or pericardial effusion
Dual-energy CT in Detecting Bone Marrow Edema of Vertebral Compression Fractures

The purpose of this study is to

1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image compared with MR imaging as standard reference.
2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual noncalcium images, such as the morphologic signs, visual qualitative detection, and quantitative values.

Patients with multiple compression fractures and in those with chronic fracture, determining which vertebra to treat is frequently difficult. In such patients, the treatment location is commonly determined from findings at imaging, which includes magnetic resonance (MR) imaging, bone scintigraphy, and computed tomography (CT).

The bone marrow edema (BME) in acute/subacute VCFs is useful in determining the vertebra that is to be treated.

MR imaging provides information on anatomic vertebral collapse and the loss of normal T1 high signal intensity from the marrow space of vertebrae with acute fractures. Loss of normal T1 high signal intensity indicates the presence of BME, which is the important sign for the PVP treatment of VCFs.

Dual-energy (DE) CT has been used to create a virtual unenhanced scan by subtracting iodine from contrast agent-enhanced CT examinations.We expect that the same technique can be used to calculate a virtual noncalcium image from an unenhanced image, which makes bone marrow accessible for CT diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Compression fractures (thoracic and lumbar vertebrae)

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Any contraindications to MR imaging.
Topical Aprepitant in Prurigo Patients

Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo


Eligibility Criteria:
Inclusion Criteria:

* Patient with Prurigo suffering from chronic pruritus
* Disease duration \> six month
* Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
* Adult male or female patients, aged 18 to 80 years

Exclusion Criteria:

* Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
* Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
* UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
* Prescribed systemic medications are limited
* Clinically significant abnormalities in Blood analyses
* Anamnestic excessive use of alcohol or tobacco or drugs
* Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)
* Known or suspected hypersensitivity to component(s) of investigational products
* Within the last 30 days or current participation in any other interventional clinical trial
* Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month
* Previously enrolled/randomised in this clinical trial
* In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
* Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding
* Females of child-bearing potential with positive pregnancy test
* Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery

The investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP) of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning.

It is essential to maintain proper cuff pressure in the endotracheal tube (ETT) when placing the ETT in the trachea in patients undergoing general anesthesia. Most of the literature recommend maintaining a pressure of 20-30 cmH2O to prevent cuff-related complications such as micro-aspiration or airway trauma. Proper pressure is also important for DLTs used in thoracic surgery. Furthermore, the cuff pressure of the ETT can change during the patient's positional changes. All things considered, we hypothesized that the change from supine to lateral decubitus position, which is essential for thoracic surgery would affect the BCP of the DLT.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 or 2
2. Elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided DLT

Exclusion Criteria:

1. Patients requiring a right-sided DLT.
2. Patients with an intraluminal lesion in the left mainstem bronchus (LMB).
3. Patients with an anatomical problem in the tracheobronchial tree.
4. Patients with impaired lung such as chronic obstructive pulmonary disease.
5. Patients who refused to participate in this study.
A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.

This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
* \>=1 measurable tumor lesion;
* ECOG performance status 0-1.

Exclusion Criteria:

* prior chemotherapy or treatment with another systemic anti-cancer agent;
* evidence of CNS metastases;
* history of grade 2 or higher hemoptysis;
* evidence of tumor invading or abutting major blood vessels;
* malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
* clinically significant cardiovascular disease;
* current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer

The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years
* Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
* Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent
* No prior chemotherapy-containing regimens for the treatment of NSCLC
* Eastern Cooperative Oncology Group performance status of 0-1
* Life expectancy of at least 12 weeks
* Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1
* Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy)

Exclusion Criteria:

* Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug
* Women pregnant or breast feeding
* Women with a positive pregnancy test result on enrollment or prior to study drug administration
* Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP
* Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases
* Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine)
* Common Terminology Criteria (CTC) Grade 2 or greater neuropathy
* Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements
* Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible)
* Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy.
* Myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months
* Known history of infection with human immunodeficiency virus
* Inadequate bone marrow function
* Inadequate hepatic function
* Inadequate renal function
* Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents containing Cremophor®EL
* Known severe hypersensitivity reaction to agents containing carboplatin and other platinum
* Prior treatment with an epothilone and/or with platinum
* History of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years
* On treatment with strong Cytochrome P450 3A4 inhibitor
* Current imprisonment
* Compulsorily detention for treatment of psychiatric or physical illness