cyrilzakka/clinical-trials huggingface dataset:
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.

PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.

OBJECTIVES:

Primary

* Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as determined by the number of retch/emesis-free days, in patients undergoing hematopoietic stem cell transplantation.

Secondary

* Determine the safety of aprepitant in these patients.
* Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens.
* Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients.

OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone.
* Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in arm I.

In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity.

After completion of study therapy, patients are followed until day 18.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.

Eligibility Criteria:
Inclusion:

* 18 years of age or greater
* must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
* Eastern Cooperative Oncology Group(ECOG) performance status \< or = 2
* patients must have signed informed consent
* must be able to swallow tablets and capsules
* must be receiving a cyclophosphamide containing regimen.

Exclusion:

* patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
* patient has received another investigational drug in the past 30 days
* patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
* patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
* patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
* patient has serum creatinine level \> or = 2\*ULN
* patient has severe hepatic insufficiency (Child-Pugh score \>9)
* patient drinks \> 5 drinks/day for the last year
* patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
Long-Term Multi-center Evaluation of E-Poly and Regenerex

There are two distinct aims of this study:

1. This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.
2. This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.


Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring primary total hip replacement
* Subjects with diagnosis of osteoarthritis or traumatic arthritis
* Subjects who demonstrate the ability to return for follow-up for the next 10 years

Exclusion Criteria:

* Subjects with limited life span
* Subjects with difficulty in comprehending study protocol for any reason.
* Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
* Subjects with avascular necrosis
* Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
* Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
* Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
* Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
Investigations of Dementia in Parkinson Disease

The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB) Positron Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to determine dementia subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be able to identify individuals with PD who are at risk of developing dementia, and to distinguish the underlying cause of dementia.

The purpose of this study is to use a brain imaging method called PIB PET and VAT PET to determine dementia subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be able to identify individuals with PD who are at risk of developing dementia, and to distinguish the underlying cause of dementia. The investigators will be including both PD and normal subjects in this study. This a long term study and we are considering including a total of 320 participants in this protocol.

Eligibility Criteria:
Inclusion Criteria:

* PD patients must exhibit three of the following cardinal signs: rest tremor, rigidity, bradykinesia, or postural instability; or two of these features with one of the first three displaying asymmetry.

Exclusion Criteria:

* history of head trauma, major neurological or psychiatric diseases other than Parkinson disease and dementia, e.g. stroke, multiple sclerosis, depression or schizophrenia.
* severe systemic diseases.
* inability to lie still for 90 minutes.
* metallic implants, pacemakers, or any other contraindication to MRI.
* refusal to consent to brain donation.
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.

The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
* Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
* Women of childbearing potential must use an acceptable contraceptive method while on study treatment

Exclusion Criteria:

* Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.

This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.

The final objective is to identify new therapeutic targets to be combined with RT.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented prostatic cancer
* Indication to perform radiotherapy treatment
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Hematological diseases
* Autoimmune diseases
* Previous neoplasias
* Prior chemotherapy or other therapies that may have violated the hematopoietic organs
* Patient's refusal to undergo periodic blood samples
Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic Floor

The objective of this study was to compare the effects of four different interventions on pelvic floor muscle electromyographic activity in women with stress urinary incontinece: i) a global osteopathic protocol (myofascial, visceral, and articular techniques), ii) one manipulation technique (high velocity, low amplitude (HVLA)/thrust) of the sacroiliac joint and T10-L2, iii) Pelvic Floor Muscle training, and iv) a control group with no intervention. The hypothesis is that the global osteopathic protocol and HVLA technique can increase pelvic floor muscle electromyographic activity to a level greater than or equal to the standard care established in the literature (pelvic floor muscle training).

Participants represented a convenience sample and were recruited from hospitals, urogynecology doctors' clinics, invitations via social networks, gyms, clubs, and sports consultants. Women had to be between 30 and 60 years old and report symptoms of urine loss due to exertion in the last six months.The participants were randomly allocated into four groups (G1 = intervention using an HVLA/thrust technique for the sacroiliac and T10-L2 joints, G2 = global osteopathic protocol, G3 = PFT, and G4 = control) by a blinded researcher with a spreadsheet of random numbers.The primary outcome measure was surface electromyography (EMG) performed at five different times: before the intervention and immediately, 30 minutes, 60 minutes, and four weeks after. This evaluation was performed by a physiotherapist with ten years of experience in urogynecology and expertise in PFM electromyographic evaluation who was blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of urine loss due to exertion in the last six months.

Exclusion Criteria:

* urgent or mixed urinary incontinency
* overactive bladder
* neurological disorder
* urinary or anal infection
* urogenital atrophy
* pelvic organ prolapse grade 3 or 4
* sensory pathways and motor not intact
* spine fracture
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study

The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest

The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition, the immediate effects such as swelling, bleeding, bruising will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female \> 18 years of age
* Need for soft tissue augmentation as evidenced by any of the following:

  * Bilateral-aging defects \> 1 on the Modified Fitzpatrick Wrinkle Scale
  * Decrease in soft tissue volume in other areas of the face

Exclusion Criteria:

* History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.
Controlling Hypertension Outcomes by Improved Communication & Engagement

This randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with VA primary care providers who provided routine outpatient medical care to these veterans. This study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the VA outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.

The communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension.

A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.

The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.

This project had a goal of enrolling 10 VA primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. The study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.

Eligibility Criteria:
Inclusion Criteria:

Veteran:

* Veteran is a patient of the enrolled provider
* History of prior stroke
* Poorly controlled hypertension with at least one measurement \>140/90 mm Hg in the past 12 months
* Complete a 6-item screen for cognitive and language impairment with a score of 3 or higher
* Sign the VA Media consent for use of picture and/or voice

Provider:

* Primary care provider, Medicine Service
* Sign VA media consent for use of picture and/or voice

Exclusion Criteria:

* Life expectancy is less than 6 months
* Non-English language patients
* Inability to provide informed consent
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to no upper limit
* Chronic pain of nociceptive, neuropathic, or mixed origin
* Patients with chronic non cancer pain
* Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
* Pain of moderate intensity (\>4, on the numerical scale 0-10) despite ongoing opioid therapy\>
* Non-pregnant, non-lactating women
* Sufficient language skills to communicate with research staff

Exclusion Criteria:Non-ambulatory patients

* Clinically significant respiratory, renal, hepatic, or cardiac disease.
* Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
* History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
* Severe depression (\> 26 on the BDI)
* Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).
* Workman compensation, current or pending medical-legal litigation
* Hypersensitivity to study medication (oxymorphone)
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Play-based Motor-Cognitive Training for Improved Reading

The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the potential effect of bodily movement on early pre-reading and word recognition skills will be explored. The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Children five to six years old who have just started school

Exclusion Criteria:

* Children who do not speak any Danish
* Children with cognitive or physical disabilities hindering participation in the project activities
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.

This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease.

Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Willing to provide informed consent
* Karnofsky performance status \&gt; 60
* Life expectancy \&gt; 6 months
* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
* Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present
* Restaging completed within 12 weeks prior to randomization (see section 5.1)
* For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
* 10 or fewer lifetime metastases from the cancer for which participants are being enrolled

Exclusion Criteria:

* Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
* For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
* Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with a member of the study steering committee.
* Malignant pleural effusion
* Inability to treat all sites of disease
* Brain metastasis \&gt; 3 cm in size or a total volume of brain metastases greater than 30 cc.
* Metastasis in the brainstem
* Clinical or radiologic evidence of spinal cord compression
* Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin
* Pregnant or lactating women