cyrilzakka/clinical-trials huggingface dataset:
Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL

This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.

Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria)
* Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
* Measurable disease (WBC \> 5,000 for CLL)
* See protocol for full list

Exclusion Criteria:

* Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
* Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
* Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
* Bulky disease by CT, defined as any single mass \>10 cm in its greatest diameter
* Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
* Known autoimmune disease or presence of autoimmune phenomena
* At least 7 days beyond any infection requiring antibiotic use.
* Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, \<20 mg/day, or equivalent) which may continue if unchanged.
* Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
Online and Narrative Interventions for Advanced Cancer Patients

The investigators will test whether narrative life review and web-based social networking for middle aged adults with advanced cancer will improve:

1. existential well being (and reduce psychological distress)
2. generativity and relationship quality, thereby mediating the intervention effects

The investigators will also conduct exploratory process analyses of each participant's social network.

Middle aged patients with advanced cancer report more distress, and active search for meaning and personal growth than older and/or early stage patients. Nonetheless, such positive growth is far from typical and interventions help. Expert-guided life review reduced distress for hospice patients, but is not widely accessible-and many patients lack the energy or skill to write their own life story. Online cancer information and support expert systems improve quality of life. Patients are increasingly developing their own social networks, but many lack the skills to do so. Moreover the effects on social networking on patient well-being have not been studied.

"My Living Story" elicits a dignity-enhancing life story via a telephone interview (based on Chochinov, JAMA 2002), and delivers the edited transcript on the patient's personal miLivingStory social network. miLivingStory links to a life review education website (called miStory) with links to high quality cancer information, support and interactive planning tools.

We hypothesize that telling, revising and sharing the life story with one's selected social network will improve the patient's existential well-being and reduce their distress. Furthermore, we hypothesize that these effects will be mediated by My Living Story's effects on improving the patient's sense of legacy (generativity) and the quality of their relationships. Our exploratory observational analyses of each individual miLivingStory network will contribute to an understanding of how social network configuration and communication patterns correlate with measured outcomes

We will recruit and randomize 100 patients with advanced cancer. The control group will receive a personalized web portal (called miOwnResources) with links to high quality cancer information, social support and interactive planning tools, and a feature to add their own links. All participants will sign informed consent forms, complete a pre-test survey and post-tests at tow and four months.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 - 60,
* Stage III or IV Cancer,
* Able and willing to use an internet computer to complete study activities.

Exclusion Criteria:

* Institutionalized, \< 6 months prognosis,
* Cannot read or understand English,
* Unable or unwilling to use an internet computer to complete study activities.
The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men

Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted in each burst. Stress-associated mechanisms introduced by acute illness and chronic disease decrease LH and Te secretion further. A major unresolved issue is whether the aging process heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te secretion. This study will assess LH and Te secretion in response to a physical stressor (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in healthy men ages 18-80 yr.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling, healthy men age 18 to 80
* Body-Mass Index (BMI) 18-30 kg/m2
* Willingness to provide written informed consent
* Physician acceptable screening ECG for participants 60 years and older

Exclusion Criteria:

* recent use of psychotropic or neuroactive drugs (within five biological half-live)
* obesity (outside weight range above)
* acute weight change (loss or gain of \>2 kg in 6 weeks
* Laboratory test results not deemed physician acceptable
* triglycerides \> 300
* BUN \>30
* creatinine \> 1.5 mg/dL
* liver functions tests twice upper limit of normal
* electrolyte abnormality
* anemia; hemoglobin \< 12.0 gm/dL
* drug or alcohol abuse
* psychosis, depression, mania or severe anxiety
* acute or chronic organ-system disease
* endocrinopathy, other than primary thyroidal failure receiving replacement
* untreated osteoporosis
* nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission)
* PSA \> 4.0 ng/mL, History or suspicion of prostatic disease (elevated PSA,indeterminate nodule or mass, obstructive uropathy)
* History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence
* History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis
* History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
* Gynecomastia \> 2 cm, untreated
* Untreated gallbladder disease
* History of smoking greater than one ppd.
Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management

Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The actual tools for evaluation of this specific part are complex and time consuming.

To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety analogic visual scale by comparison with the actual reference the self-assessment questionnaire State Trait Inventory Anxiety Y-A form.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old
* Perfect patient ability to understand and write French
* Patient with a pain threshold permitting a initial medication free consultation and completion of anxiety surveys.

Exclusion Criteria:

* Inability of patient to understand the study procedures and thus inability to give informed consent.
The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community

This study is a controlled, cluster randomised, interventional trial to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in an extensive working population.

Many studies were performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting.

In a previous non-randomized-controlled study in which the cognitive and physical programme was applied to a consistent number of office workers, a significant reduction of frequency of pain in the head and neck areas and of analgesic drug consumption was obtained. The present study was designed to confirm the data in a much more extensive working population and applying a randomised design.

The primary objective is to confirm the effectiveness of a workplace cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large working community using a randomized design.The Intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce parafunction and hyperfunction of the craniofacial and cervical muscles during the day.

Secondary objectives:

To confirm the effectiveness of the Intervention, in reducing the intensity of pain involving the head and neck area in a large working community using a randomized design.

To confirm the reduction in analgesic drugs consumption after the Intervention in a large working community using a randomized design.

To evaluate the persistence of the effectiveness of the Intervention after 12 months in a large working community using a randomized design.

Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).

Eligibility Criteria:
Inclusion Criteria:

* All the subjects employed at the Municipality of Turin at September, 2007 will be recruited.

Exclusion Criteria:

* Because of the pragmatic design, no exclusion criteria are required for this study.
Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates among mothers of premature newborns.

Hypothesis: Music therapy applied to mothers of premature newborns increases the rates of maternal breastfeeding at the time of the infant hospital discharge and at follow-up visits.

Music therapy has been shown to have positive effects in several areas such as mental health, special education, rehabilitation and social development. Its use as a means to facilitate communication and expression of emotional contents was shown to be able to promote relief of anxiety, fears and tensions. However, in the maternal and child health area there are still few studies demonstrating the contribution of this therapy in the promotion of health and no study evaluating specifically the impact of this intervention on the rates of breastfeeding in mothers of premature newborns.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of premature newborns, with birth weight ≤ 1750 g that have reached clinical stability defined by the medical staff.
* To have signed an informed consent to participate in the study.

Exclusion Criteria:

* Mothers that are HIV (Human Immunodeficiency Virus) positive.
* Mothers of neonates with clinical problems that impaired breast suction (encephalopathy with serious hypotonus, oro-facial anomalies, and heart problems).
* Mothers with severe hearing deficiencies.

Exit Criteria:

* Mothers whose neonates died during the hospital stay.
* Mothers who, for any reason, had three or less music therapy sessions.
Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment.

Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal before the second year of life. CP consists of different aspect of motor disorder including spasticity, paresis, incoordination and dystonia

There is scarce knowledge about the association between spasticity, pain and physical function in the adult CP-population, and the systematic follow up of patients with CP typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and thigh muscles, and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation.

Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity. The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al. Subsequently, randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that there is no indication for this treatment in the adult CP-population.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral spastic CP
* Modified Ashworth Scale (MAS) ≥ 2 in ankle- or knee joint muscles.
* ≥ 18 year of age, ≤ 65 year of age
* Ambulant without walking aids minimum 10 metres in functional equines and/or with pathological knee extension or flexion pattern.

Exclusion Criteria:

* Cognitive impairment.
* No spasticity (MAS \< 2 )
* \< 18 year of age
* Not ambulant without walking aids
* Pregnant or planning pregnancy
* Btx-A treatment last 6 months
* Orthopedic surgery lower extremity last 18 months
* Obvious skeletal/joint deformity where orthopedic surgery is indicated
* Other diseases which can affect level of function (rheumatoid or neurological )
* New treatment the past four weeks which affect the musculoskeletal system (pain killers, physical therapy, acupuncture)
Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

Glaucoma is a common eye disease that can lead to blindness. The only known way to reduce the rate of disease progression is by reducing the pressure in the eye (the intraocular pressure, IOP). Selective laser trabeculoplasty (SLT) is an ophthalmic laser intervention with the purpose of reducing the IOP.

SLT can be performed in different ways, with four of the treatment protocols being evaluated in the Optimal SLT (OSLT) trial.

SLT is a repeatable procedure, but scientific evidence is scarce regarding more than one repetition. In this trial, patients included in the OSLT trial will be invited to the extended trial (OSLT-R), for further follow-up and re-treatment with SLT, if needed.

Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) at the time of SLT re-treatment or when OSLT follow up is scheduled to terminate. Patients are re-treated as needed, according to the randomized group assignment performed in the OSLT inclusion process.

The OSLT-R trial is aiming to elucidate:

* If the SLT efficacy, in terms of relative IOP reduction (percent of baseline IOP), changes with additional SLT iterations.
* If the longevity of IOP reduction after SLT changes with additional SLT iterations.
* If repeated SLT is associated with a change in postoperative discomfort or adverse events.

All of the above will be analyzed within each of the four treatment groups (SLT protocols) in the trial. Further, analysis will also be conducted regarding differences between the treatment groups regarding the above.

Further, analysis will be performed regarding SLT efficacy depending of the total number of SLT:s an eye has received, including those performed before entering the OSLT and OSLT-R trials.

Eligibility Criteria:
Inclusion Criteria:

* Included in the OSLT trial
* Followed up without the need for other treatment escalation than repeat SLT

Exclusion Criteria:

* Unable to participate in follow up due to health conditions, strength or physical location.
Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial

Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This feasibility pilot study will be conducted with 6 hospitals at two large U.S. health systems and enroll 540 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. In this cluster-randomized trial, the 6 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalists are trained using the Center to Advance Palliative Care (CAPC) online trainings. The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial (e.g., are the interventions working as intended). This pilot feasibility study is the precursor to a much larger pragmatic, hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older; AND
* Predicted 1-year mortality risk of 60% or greater; AND
* Admitted to a study hospital.

Exclusion Criteria:

- Patients who die or have an active or completed discharge order prior to enrollment time
Blood Pressure Monitor Clinical Test (Cuff Range: 13.5 Cm-22cm)

The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 13.5 cm-22 cm.


Eligibility Criteria:
Inclusion Criteria:

* cuff circumference: 13.5cm-22cm
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation

At present, a specific community based rehabilitation programme for lung or heart-lung transplant recipients does not exist. 160 hospitals throughout the United Kingdom (UK) offer pulmonary rehabilitation programmes. The programmes operate under evidence-based guidelines as outlined by the Chartered Society of Physiotherapy. Increasing evidence shows that rehabilitation programmes help improve performance, exercise endurance, and quality of life; and reduce symptoms and demand on health-care resources. This study proposes to compare the outcomes of lung and heart-lung transplant patients attending local pulmonary rehabilitation against others receiving the Trust's current document-based programme. The study is a randomized controlled trial:

* Control Arm: Those patients randomized to the 'control' arm will receive the Trust's standard rehabilitation programme that consists of an information pack supplied upon discharge. They will then complete and undertake the following tests: Short-Form 36 (SF 36; version 2) Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental Shuttle Walk Test and Spirometry forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC). The patient will follow the information contained in the information pack and the above tests and questionnaires will be repeated 6 months post discharge.
* Experimental Arm: A patient who is randomized to the 'experimental' arm will be asked to complete the following tests upon discharge: Short-Form 36 (SF 36; version 2) Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental Shuttle Walk Test and Spirometry FEV1 and FVC. Three months post discharge, the patient will be enrolled into a local pulmonary rehabilitation programme. The programme is typically structured to last 6-12 weeks. The above tests and questionnaires will be repeated 6 months post discharge.

To measure the effectiveness of either the information pack or the rehabilitation programme the following endpoints will be subjected to analysis in both the experimental and the control group:

* Short-Form 36 Questionnaire;
* Chronic Respiratory Questionnaire;
* Incremental Shuttle Walk Test;
* Borg Scale;
* Spirometry FEV1 and FVC;
* Hospital re-admission rates and mortality rates.

The undertaking of a multidisciplinary-led programme of rehabilitation facilitates a better quality of life than a document-based rehabilitation programme in lung and or heart-lung transplant out-patients.

The aim of the study is to construct an optimal programme of rehabilitation in lung or heart-lung patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have undergone either a lung or heart-lung transplant.
* Fit for discharge from the Transplant Unit's Intensive Care Unit.
* \> 18 years of age.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients unable to understand or comprehend the study.
68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma

This is a prospective pilot proof-of-concept single-center study. Primary Objective Using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with Hepatocellular Carcinoma (HCC) undergoing surgical resection or transplant:

1. To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC
2. To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s).
3. To perform a Radiology-Pathology correlation of PSMA uptake at PET with HCC tumor PSMA immunostaining, tumor pathology features, and signal and enhancement characteristics at MRI

Eligibility Criteria:
Inclusion Criteria:

* Patients at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC confirmed by a hepatobiliary pathologist
* No prior treatment for HCC
* Subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant
* Male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent.

Exclusion Criteria:

* Subjects requiring emergent surgery for a ruptured/bleeding HCC
* Bilirubin \> 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent
* Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan.
* Subjects with higher than the weight/size limitations of PET/MRI scanner.
* Subjects with contraindication to MRI including: Subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants
* Subjects with history of allergic response to radiocontrast media
* Subjects with known history of claustrophobia.