cyrilzakka/clinical-trials huggingface dataset:
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute myelogenous or lymphoid leukemia
* Chronic myelogenous leukemia in accelerated phase or blast-crisis
* Chronic myelogenous leukemia in second or subsequent chronic phase
* Recurrent or refractory malignant lymphoma or Hodgkin's disease
* Multiple myeloma at high risk for disease recurrence
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features
* Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
* Myelodysplastic syndromes (including PNH) with \> 5% blasts
* Zubroid performance status \< 2 (See Appendix B)
* Life expectancy is not severely limited by concomitant illness
* Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
* Calculated Creatinine Clearance \> 50 ml/min
* Serum bilirubin 2.0 mg/dl, SGPT \< 3x upper limit of normal
* No evidence of chronic active hepatitis or cirrhosis
* HIV-negative
* Patient is not pregnant
* Patient or guardian able to sign informed consent

Exclusion Criteria:

* Clinical progression
The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy

This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.

Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune repertoire (IR) in autoimmune disease states. To further explore the potential application value of this technology, we will conduct a series of prospective studies to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.

Eligibility Criteria:
Inclusion Criteria:

1. IgA nephropathy:

1. Age: 18-80 years.
2. Patients diagnosed with primary IgA nephropathy by renal biopsy.
3. Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m\^2.
4. Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity matched health volunteers. 3. IgAN patients were further divided into 4 groups, as defined below:

1) Long-term stable patients:

Follow-up for at least 15 years and meet at least one of the following:

1. Annual eGFR loss rate \<3ml/min/1.73m\^2.
2. eGFR\>90ml/min/1.73m\^2. 2) Non-progressive IgAN patients:

Meet at least one of the following:

1. eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).
2. Annual eGFR loss rate \>5ml/min/1.73m\^2.
3. Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤ 1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of disease progression: Proteinuria \> 1g/24h despite 3 months of optimized supportive care.

Exclusion Criteria:

1. Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
2. Patients with secondary IgAN;
3. During pregnancy or lactation;
4. After kidney transplantation;
5. More than one serious acute infection in the psat 12 months;
6. Chronic infection;
7. Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;
8. Incomplete medical history or clinical data.
Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer

RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.

OBJECTIVES:

Primary

* To determine energy and protein consumption on an average radiotherapy treatment day using the multiple pass method 24-hour analysis of food recall at baseline and treatment end.
* To compare energy and protein by mouth intake from baseline to treatment end.
* To measure and compare diet quality from baseline to radiotherapy treatment end by Healthy Eating Index (HEI) score.
* To determine lean body mass versus fat mass using a bioelectrical impedance analysis machine.
* To compare body fat to lean body mass percentage at baseline with that at radiotherapy treatment end.
* To correlate energy and protein consumption with lean body mass at baseline and treatment end.
* To determine the change in appetite throughout radiotherapy by comparing data obtained by interview at baseline and radiotherapy treatment end.
* To determine the change in performance level (Karnofsky percentage) associated with the radiotherapy through a series of questions asked at baseline and treatment end.

OUTLINE: Patients receive radiotherapy as planned for 7 weeks. Patients undergo an interview on treatment day 1 (before initiation of radiotherapy) and treatment day 35 (after completion of radiotherapy) regarding recent food consumption history and appetite. Patients' standing weight and height are measured on these days and their body composition, measured with a bioelectrical impedance analysis (BIA) device, are also taken. Patients' Karnofsky performance score are obtained from their medical record.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with stage III non-small cell lung cancer (NSCLC)
* Plan to begin radiotherapy for NSCLC

  * Radiotherapy is the only planned therapy for this cancer
* No brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Must be able to stand without assistance

Exclusion criteria:

* Unable to comply with study requirements
* Native language other than American English
* Pacemaker or implanted defibrillator

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

* Receiving chemotherapy in combination with radiotherapy
* Concurrent megace or steroids
HRV and Pain Intensity

The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pain for at least 3 months
* Age \> 18 years
* Patient has been informed of the study procedures and has given written informed consent
* Patient willing to comply with study protocol

Exclusion Criteria:

* Healthy patients or patients with acute pain.
* Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
* Patients were excluded if they had one or more coexisting conditions known to affect HRV analysis.
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children

The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children.

The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.


Eligibility Criteria:
Inclusion Criteria:

* orotracheal intubation under general anesthesia

Exclusion Criteria:

* oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation
Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study

Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Most of them (73% - 90%) can be managed conservatively.Despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. Because of the nature of the disease recurrence has been estimated to be 30%.Many attempts to prevent formation of postoperative adhesions have been tried. In this trial, we will study the effect of corticosteroids and FFP in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.


Eligibility Criteria:
Inclusion Criteria:

* Patients with attacks of adhesive intestinal obstruction

Exclusion Criteria:

* Associated abdominal malignancy, patients with adhesive IO who respond to conservative treatment.
Validation orthèse Pour Gonarthrose

A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.

There are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. Three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. Therefore, different configurations exist to reduce biomechanical deficits caused by the pathology.

Each fastening system has its advantages and disadvantages. Velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. Cable fastening systems also use quick-release fasteners. The adjusment process is simple and precise with minimal noise with these systems.

Comfort, efficacy and ease of use are essential qualities of a knee brace. Confort is primordial as it is directly linked to treatment adherence by the patients. Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. Ease of use must be optimized as it presents an opportunity to increase treatment adherence. The goal of the fastening system developped in partnership with Laboratoires Victhom is the increase the ease of use of the knee brace while maintaining comfort and treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Has worn an ODRA knee brace multiple hours a day during the last 6 months

Exclusion Criteria:

* Wounds on the lower body
Health Effect of Canola Oil Consumption in Shift Workers

Shift work is associated with a higher risk of the development of cardiometabolic syndrome (CMtS) than in people working only during the day. One of the factors predisposing to the development of the CMtS in shift workers is an inappropriate composition of their diet. It was observed that the shift workers diet is characterized by a higher intake of saturated fatty acids (SFA) and a lower consumption of unsaturated fatty acids. One potential way to reduce the risk of CMtS in this study group seems to be a modification of their everyday diet by excluding the products of animal origin (e.g. butter) with simultaneously including vegetable oils (i.e. canola oil). The aim of the study is to evaluate the effect of replacement in the everyday diet of saturated fats (butter) with unsaturated fats (canola oil-based spread and canola oil added to main meals) in centrally obese shift workers on changes in body weight and body composition parameters as well as on changes in CMtS markers.

The study was designed as a randomized clinical trial to investigate the effects of the dietary intervention with moderate in fat content (\~35% energy as fat) for 12 weeks on the improvement of cardiometabolic risk factors in centrally obese shift workers. Forty centrally obese shift workers (waist circumference ≥94 cm) were randomized (1:1) to the experimental group (n = 20) or the control group (n = 20). Eligibility criteria included: aged between 30-60 years, working rotating shifts for at least 5 years and working night shifts minimum five times a month. Excluded criteria was described in the point "Eligibility". Written informed consent was obtained from all of the participants, and the local ethic committee approved the study. The dietary intervention was mainly based on the simple rearrangement of shift workers' diets by replacing food items including SFA (e.g. butter) with those being sources of unsaturated fatty acids (UFA), mainly canola oil (given to the diet as spread or this oil was added separately to main meals)

Eligibility Criteria:
Inclusion Criteria:

* centrally obese (≥ 94cm) male
* aged between 30-60 years,
* working rotating shifts for at least 5 years and working night shifts minimum five times a month,

Exclusion Criteria:

* diabetes, familial hypercholesterolemia, thyroid and parathyroid diseases, non-specific intestinal diseases, celiac disease, phenylketonuria,
* taking medication for lowering blood lipids such as statins,
* weight loss therapy for 3 months before the intervention,
* allergies and intolerances
* consuming high-proof alcoholic beverages (\>2 portions/week)
Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS).

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS), various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with CVS.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent.

Exclusion Criteria:

* Subjects age \> 22 years old Vomiting is not due to CVS or other related condition
Synaptic Plasticity in the Epicardial Ganglionated Plexi

Atrial fibrillation (AF) is the most common arrhythmia and the prevalence increase with age. Autonomic nervous system play a critical role in the initiation and maintenance of AF. The intrinsic cardiac autonomic nervous system includes ganglionated plexus (GP) modulate the level of parasympathetic activity to the heart. Experimental and clinical studies suggest that GP activation plays a significant role in clinical AF in both the initiation of and the maintenance of AF.

Synaptic plasticity is defined as the ability of synapses to change their strength of transmission. Plasticity of synaptic connections in the brain is a major focus of neuroscience research, as it is the primary mechanism underpinning learning and memory. Beyond the brain however, plasticity in peripheral neurons is less well understood, particularly in the GP neurons innervating the heart. The ability of these neurons to alter parasympathetic activity suggests that plasticity may indeed occur at the synapses formed on and by GP neurons. Such changes may not only fine-tune autonomic innervation of the heart, but could also be a source of maladaptive plasticity during atrial fibrillation.

Low level tragus stimulation (LLTS) has been shown to decrease AF burden among patients with paroxysmal AF. However, the exact mechanism remains unclear. The objective of this study is to examine changes in synaptic density of GP neurons in patients with paroxysmal AF and persistent AF compared to those without AF undergoing cardiac surgery. In addition, we aim to examine the effect of LLTS on the synaptic plasticity of the GP neurons. A group of patients undergoing open heart surgery will be randomized to active LLTS for 30 min (pulse width of 200 μs, amplitude of 20 mA and a pulse frequency of 20 Hz) or no stimulation. Biopsy from GP tissue will be taken immediately after stimulation and histological staining for choline acetyl transferase (ChAT), tyrosine hydroxylase (TH) and synaptophysin will be performed to examine synaptic plasticity.

Understanding the effect of LLTS on GP SP will help to determine whether changes in synaptic plasticity can increase or decrease autonomic tone of the heart, and its role in generating the aberrant electrical impulses in the GP around the pulmonary veins that can trigger and drive AF.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients older than 21 year old
2. Patient is going to have open heart surgery.

Exclusion Criteria:

1. Patients undergoing emergent open heart surgery.
VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities

The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Hispanic or Latino
* be present at the corner for the purpose of looking for work

Exclusion Criteria:

* have not been previously hired to work at a corner
* symptoms of COVID-19 in the previous 48 hours
A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials

The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Patients older than 18
* Teeth must receive endodontic therapy before restoration
* The periodontal condition had to be stabilized before restoration
* No subject complained of discomfort in teeth
* Radiograph revealing alveolar bone resorption of less than a third and no shadow around the periapical tissues
* Participants who provided writen informed consent were recruited in collaboration

Exclusion Criteria:

* Any teeth with microcracks or fracture lines
* Affected teeth without completed root canal treatment
* The defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level
* Poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education
* Bruxism or clenching patients
* Poor general health or pregnancy
* Patients who have read the informed consent form and refused to be included in the study
Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue

The primary objective of this study is to determine if exercise, fasting, or eating prior to the molecular breast imaging study will have an effect on the uptake of the tracer in the breast tissue.

The primary objective of this study is to determine if exercise, fasting, or eating prior to a molecular breast imaging study will have an effect on the uptake of the radiotracer Tc-99m sestamibi in the breast tissue.

Tc-99m sestamibi is primarily extracted by the liver. Changes in hepatic blood flow may therefore influence the amount of radiotracer available for uptake in the breast tissue.

Eligibility Criteria:
Inclusion criteria:

Arm 1: 1. Able to fast overnight or for 6 hours 2. Non-diabetic 3. Age \> 40 years 4. Negative pregnancy test, postmenopausal, or surgically sterilized 5. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment) 6.No current breast concerns

Arm 2: 1. Able to fast overnight or for 6 hours 2. Able to perform light to moderate exercise on an exercise bike 3. Non-diabetic and Body Mass Index \< 25 4. Age \> 40 years and \< 70 years 5. Negative pregnancy test, postmenopausal, or surgically sterilized 6. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment) 7. No current breast concerns 8. No history of coronary artery disease, angina, stroke or peripheral arterial disease.

Arm 3: 1. Able to fast overnight or for 6 hours 2. Willing to consume a dose of caffeine (200 mg), equivalent to that of an 8 oz Starbuck brewed coffee.

3. Non-diabetic 4. Age \> 40 years 5. Negative pregnancy test, postmenopausal, or surgically sterilized 6. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment) 7. No current breast concerns

Arm 4: 1. Able to fast overnight or for 6 hours 2. Non-diabetic 3. Age \> 40 years 4. Negative pregnancy test, postmenopausal, or surgically sterilized 5. Negative mammogram at Mayo Clinic within the last 15 months (defined as screening mammogram or subsequent diagnostic workup with BI-RADS 1 or 2 final assessment) 6. No current breast concerns

Exclusion Criteria:

* Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test
* Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2 hour period.
* Have undergone unilateral or bilateral mastectomy
* Breast implants or silicone injections
* Are unable to understand and sign the consent form
* Arm 2-also includes: Unable to perform light to moderate exercise for 12 minutes on a treadmill or a stationary bicycle
* Arm 3: Unwilling to consume a 200 mg dose of caffeine
Comparing the Effects of Upper and Lower Body Resistance Training on Pain Sensitivity

Resistance exercise may immediately lessen the perception of pain. The purpose of this study is compare the effects of an upper body exercise to a lower body exercise on the perception of pain (pressure pain threshold).


Eligibility Criteria:
Inclusion Criteria:

* pain free

Exclusion Criteria:

* non-English speaking
* regular use of prescription pain medications
* current or history of chronic pain condition
* currently taking blood-thinning medication
* any blood clotting disorder
* medical conditions known to affect sensation, such as: uncontrolled diabetes or neurological conditions
* any contraindication to the application of ice, including: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* surgery, injury, or fracture within the past 6 months
* unable to perform exercise portions of the study
* unable to attend three sessions
* pregnant