cyrilzakka/clinical-trials huggingface dataset:
UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.

This trial will determine the maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have symptomatic multiple myeloma requiring treatment
* Patients must have been approved for single or tandem autologous transplant
* Patients must be \> or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine \> 3 mg/dl or a creatinine clearance \< 30 ml/minute
* Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) \> 50% of predicted,
* Patients must have an ECHO or MUGA performed within 60 days prior to registration, LVEF \> 40%.
* Bilirubin, SGOT, SGPT must be less than 1.5 times the upper limit of normal
* Patients must have evaluable myeloma marker for response such as: \*Serum M protein \>1g/dl or urine M protein \>1g/24 hours and/or; \*Bone marrow plasmacytosis with \>20% plasma cells and/or; \*Extramedullary plasmacytosis; \*MRI/PET scan has focal lesions due to myeloma.
* Patients must be able to receive full doses of DT-PACE, in the opinion of the treating investigator, with the exception of cisplatin.
* Patients must have a performance status of 0-2 based on SWOG criteria unless the patient's status is due to active myeloma
* All patients must be informed of the investigational nature of the study and have signed an IRB-approved informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Serum transaminases \> 1.5 x ULN and direct bilirubin \> 1.5 mg/dl
* HIV positive or active Hepatitis B or Hepatitis C infection; (if serology is positive a quantitative PCR will be done).
* Patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. Patients must not currently be receiving therapy for the prior malignancy.
* Pregnant or nursing women. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Eye Movement Desensitization and Reprocessing (EMDR) to Treat Chronic Pruritus

Pruritus is a common symptom of numerous dermatological and non-dermatological conditions. Current treatments for chronic pruritus (CP) are often not fully effective and may have burdensome side effects. Recently, the trauma exposure technique Eye Movement Desensitization and Reprocessing (EMDR) that is recommended as first line treatment for posttraumatic stress disorder has been reported to be also effective in the treatment of CP in anecdotal clinical case observations. However, to the best of the investigator's knowledge, the efficacy of EMDR in CP has not yet been systematically explored. This study aims at addressing this unmet need in a prospective pilot study comparing EMDR versus treatment as usual (TAU).


Eligibility Criteria:
Inclusion Criteria:

* Provided written informed consent
* Age 18 to 75 years
* Skindex-29 (questionnaire) symptoms subscale ≥42
* Confirmed diagnosis CP
* Itch intensity of min. ≥ 4 on the 0-10 numerical rating scale within the last 7 days
* Stable course of treatment in the two weeks prior to the study

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g. due to language problems, severe psychiatric disorders such as delusional disorder, suicidality or dementia.
* Patients on phototherapy
* Acute attacks of an autoimmune disease such as Crohn's disease
* Serious cardiac disease
Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for gastrointestinal endoscopic procedures
* ≥ Age 18 years
* ASA I-II

Exclusion Criteria:

* Allergy to any of the used drugs
* impaired renal or liver functions
* hypertensive patients
* patients with cardiovascular
* cerebrovascular disease
HRV in Patients Treated With Spinal Cord Stimulation

This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old.
* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
* Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion Criteria:

* The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
* The use of medication that directly modifies autonomic control (for example beta-blockers).
Utility of Postoperative Bracing

The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity.

If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment.

Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* The principal investigator's new or returning patients
* Adults 18 to 80 years of old
* Undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity

Exclusion Criteria:

* Patients who are undergoing a spinal fusion for other reasons besides deformity
* Patients who are unable to provide consent or fill out survey questionnaires
* Patients who have brace-prohibitive body habitus
* Patients who are unable to obtain standing AP and lateral 3-foot standing scoliosis x-rays
Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy

This study aims to estimate the effects of nutritional interventions on the improvement of nutritional status and quality of life (QoL) among gastrointestinal patients in Vietnam

A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care - Medical University Hospital from 2016 to 2019. 60 gastrointestinal cancer patients were recruited in each group. At stage 1, we selected patients of the intervention group who met the inclusion criteria to receive nutritional counseling and diet at the hospital. At stage 2, we chose patients who were eligible but did not accept the nutritional counseling and diet at the hospital. Participants in both groups were paired together according to the following criteria: 1) Age group: \<40 years old, 40-65 years old and \>65 years old; 2) Gender: Male and female; 3) Types of cancer: stomach cancer and colon cancer; 4) Disease stages: stage 1-2 and stage 3-4.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years old or above
* diagnosed with stomach or colon cancer;
* at the initial of receiving chemotherapy treatment;
* indicated for oral feeding;
* not having co-morbidities of chronic diseases such as kidney failure, heart failure, liver failure, diabetes;
* having ability to communicate with data collectors and both attending doctors and agreeing to involve in the study

Exclusion Criteria:

* treated by other methods such as radiation, endocrine, immunity;
* undergoing terminal palliative care;
* having contraindications to oral feeding/enteral nutrition
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24

Not provided

Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females aged 19 years or older on the day of informed consent
2. Subjects requiring continuous treatment or receiving treatment with NSAIDs
3. Subjects with at least one of following peptic ulcer risk factors at the time of Screening
4. Subjects who have provided voluntary informed consent for the study participation after the study is explained

Exclusion Criteria:

1. Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
2. Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
3. Subjects with confirmed history of malignancy within 5 years prior to Screening
4. Positive human immunodeficiency virus (HIV) antigen/antibody at Screening
Prevention Management Model for Early Childhood Caries (MAYA Project)

The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.

The primary aim is to evaluate two programs, a minimal intervention program and a moderate intensity program, for preventing Early Childhood Caries. A four-year randomized clinical trial will be conducted specifically to: 1) Assess demographic and behavioral factors as predictors of ECC and the relationship between three-year post-intervention behavioral changes from baseline measures with disease outcomes; 2) Compare the efficacy for the prevention of ECC in two groups - the minimal intervention group (Group 1) receiving counseling alone, with the moderate intensity group (Group 2) receiving a) counseling and a therapeutic four-month regimen of Chlorhexidine rinse for new mothers and b) fluoride varnish applications for their infants and toddlers starting at twelve months of age and continuing to age 30 months; 3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures with disease outcomes; 4) Assess the impact of a caries-preventive model in lowering the salivary mutans streptococci level in post-partum women, and subsequently, in inhibiting the growth of these bacteria in their young children, delaying the infectious process.

The long term objectives are to build upon our understanding of caries risk factors, to assess the effectiveness of a prevention management model, to improve access to preventive oral health services and information for low-income pregnant women and their young children, and to reduce oral health disparities in a border population (U.S. - Mexico Border near San Diego Bay Area) at high risk for dental disease.

Eligibility Criteria:
"Inclusion Criteria"

* Some evidence of geographic stability in South San Diego Bay Area
* Planning on remaining in area approximately 3 years after birth of child
* Must be able to provide consent in English or Spanish
* Must be registered patients at San Ysidro Health Center in the prenatal program
* Must be experiencing a normal pregnancy

"Exclusion Criteria"

* Diabetes, anemia, placenta previa, seizure disorders, GDM, evidence of chromosomal disorders, Polyhydramnios, Thrombophlebitis, or RH-negative status
* Vaginal bleeding, premature uterine contractions, viral or bacterial infections, diabetes, pregnant with twins or multiple births expected
* Previous pregnancy complications where hospitalization was required
Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.

The goal of this phase 2, multicenter, randomized, controlled study is to evaluate the effect of albumin treatment on B cell and other immune cell gene exptression in adults with septic shock.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years and \<85 years of age.
2. Community-acquired pneumonia, urinary, skin or biliary infection.
3. Treatment with antibiotics at least one course in the first 6 hours of suspected infection.
4. Meets Septic Shock criteria defined by the presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4h to maintain MAP\>65 mmHg and having a serum lactate level \> 2mmol/L (18mg/L).
5. SOFA score ≥ 5 points.
6. Albumin plasma level \<35g/L.
7. Lymphocytes count \< 1,100 cel/mL.
8. Admitted to ICU or IMU

Exclusion Criteria:

1. Septic shock lasting for more than 24h.
2. ECMO or hemoadsortion therapy.
3. Contraindications to receive albumin.
4. Nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis).
5. Chronic Renal Failure (KIDGO stage 3-5) or dialysis.
6. Liver cirrhosis.
7. A known malignancy that is progressing or has required active treatment within the past 3 months.
8. Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live \< 6 months (as assessed by the study physician).
9. Known New York Heart Association (NYHA) class II to IV heart failure or unstable angina, acute coronary disease or myocardial infarction within 6 months prior to diagnosis of sepsis.
10. Known immunocompromised state, including human immunodeficiency virus infection, or medication known to be immunosuppressive.
11. Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.
12. Likely to be non-compliant or uncooperative during the study (e.g. substance abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with the study).
13. Albumin administration within the last 14 days.
14. Subjects with severe neurological or severe head trauma disorders.
15. Pregnant and/or breast-feeding woman.
16. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision marker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease

The goal of this study is to investigate neurophysiologic tests that have the potential of serving as screening tools for Parkinson's disease. These neurophysiologic tests will be administered to individuals with Parkinson's disease and parkinsonian syndrome and validated against a healthy control population.

Specifically, this study will look at changes in motor function, cognitive function, handwriting, speech, and olfactory function in individuals with Parkinson's disease, individuals at risk for Parkinson's disease and healthy controls.

One of the greatest challenges in Parkinson's research is the identification of individuals who are at risk or have early Parkinson's disease (PD) or parkinsonian syndrome (PS). Subtle signs that do not meet the diagnostic criteria for PD may occur during this period.

This study will evaluate a profile of neurophysiologic tests for potentially predictive signs of PD or PS in individuals with PD or PS, those who may be at risk for PD or PS and in a population of individuals without parkinsonian symptoms or any other neurologic conditions.

In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson's disease or parkinsonian syndrome.

Each study participant will be scheduled for a 90 minute study visit.

This visit may include the following procedures:

* Screening for eligibility
* Clinical assessments
* Neurological evaluation
* Computerized cognitive testing
* Olfactory testing
* Computerized handwriting testing
* Speech evaluation
* Blood sample for biochemical and/or genetic analysis

The study will be conducted at the Institute for Neurodegenerative Disorders (IND), which is a not for profit research institute specializing in Parkinson's disease research.

Clinical data will be collected, stored and analyzed at IND to evaluate whether there are significant differences between the performance of the parkinsonian study participants, individuals with risk factors for PD or PS, and the healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

As a participant with PD or PS:

* Age \>21
* Clinical diagnosis of PD or PS (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) and a clinical response to dopaminergic therapy

For Healthy Control:

* Age \>21

Exclusion Criteria:

As a participant with PD or PS:

* Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks tested in this study (e.g. stroke, demyelinating disease, visual loss)

For Healthy Control:

* Any indication of parkinsonism on examination
* Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks (e.g. stroke, demyelinating disease, visual loss)
Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea

Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward on upper airway is not completely known. In this study we will use both static and dynamic MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract at different mandible posits. Because in asian society non-obese OSA patients are not uncommonly seen, in this study we focus only on non-obese severe OSA patients.

The aim of this study is to analyze upper airway morphology changes and dynamic movement at different sections affected by mandible position by using dynamic and static magnet resonance imaging technique. The study also discusses the formation mechanism of obstructive sleep apnea syndromes and function mechanism of the oral appliance, as well as the evaluation of the clinical results of the oral appliance on non-obese male patients with severe obstructive sleep apnea in Taiwan.

10 non-obese (BMI\<25) severe OSA (AHI\>30) male patients between the age of 20 to 60 and 10 gender, BMI and age matched control (AHI\<5) were recruited for this study. Nine bite index were made for the different mandible positions of the subjects.

Upper airway was imaged by using static and dynamic MRI of each subject wearing the bite index while lying on the MRI scanning table. This study also measures the circumference and takes the lateral cephalometric imaging of each subject. Oral appliances were made and fitted for the experimental group subjects, who wore them for three months, after which they transferred to the Sleep Center and underwent PSG examination to evaluate therapeutic effects of the appliances.

Eligibility Criteria:
Inclusion Criteria:

* Severe obstructive sleep apnea (AHI\>=30/hr) age, sex, BMI match control subject

Exclusion Criteria:

* Patients were excluded when:

  * (1) refused to participate in this study,
  * (2) had severe obstructive pulmonary disease or active neurological events,
  * (3) enrolled in other studies at the same time
Physical Training in Patients With Idiopathic Inflammatory Myopathies

Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.

To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975)
* Both genders and age ≥ 18 years
* Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study
* Physically inactive

Exclusion Criteria:

* Disease relapsing
* Neoplasia associated-myositis
* Overlapping myositis
* Use of lipid-lowering drugs
* Smoking
* Diabetes mellitus
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
* msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004

Exclusion Criteria:

* Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
* Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
* msSBP ≥ 25% above the 95th percentile
* Second or third degree heart block without a pacemaker
* AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range
* Total bilirubin \> 2 times the upper limit of the reference range
* Creatinine clearance \< 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate \[GFR\]), based on the serum creatinine concentration obtained at the screening visit)
* WBC count \< 3000/mm³

Other protocol-defined inclusion/exclusion criteria may apply