cyrilzakka/clinical-trials huggingface dataset:
Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury

Chronic pain after spinal cord injury in or below the level of injury is a common problem and can be severe.

The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury.

The study is a controlled simple blind randomized prospective study. Subjects who live in Trøndelag ( Norway) and who have a traumatic or non traumatic spinal cord injury with chronic pain in or below the level of injury will be included in the study.

Assessments: Pain will be measured with NRS(numeric pain rating scale) and BPIQ (Brief pain intervention questionnaire), anxiety and depression with BDI and BAI (Beck's depression and anxiety inventory) and quality of live with SF36 health survey.

The subjects will be randomized in a treatment and control group. One group will use daily for four weeks a CD with a pleasant guided imagery, the other group will write a short pain diary.

The NRS will be registered daily and the other assessments before and after the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway)

Exclusion Criteria:

* Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder
Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 70 years old (including 18 and 70)
2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
3. Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)
4. Having at least one measurable lesions
5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
6. Life expectancy no less than 1 month
7. enough main organ function
8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as secondary central nervous system lymphoma
2. Diagnosed as CD20 negative large B cell primary central nervous system lymphoma
3. Active malignant tumor need be treated at the same time
4. Other malignant tumor history
5. Serious surgery and trauma less than two weeks
6. Patients with active tuberculosis
7. Systemic therapy for serious acute/chronic infection
8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
9. HIV-positive, AIDS patients and untreated active hepatitis
10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
11. Patients with a history of mental illness or drug abuse
12. Poor compliance during the trial and/or follow-up phase
13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
14. Researchers determine unsuited to participate in this trial
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with OUD and their infant
* Currently on BUP/METH for OUD
* Enrolled in prenatal opioid maintenance program
* Age \>18 years
* Singleton pregnancy
* Planned delivery at UPMC's Magee Womans Hospital
* Positive opioid urine screen results

Exclusion Criteria:

* Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
* HIV or AIDS
* Known major fetal congenital abnormalities
Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression

The study was designed to examine the efficacy and tolerability of quetiapine XR for the treatment of women who suffer from depression in the context of the menopausal transition and postmenopausal years. Besides the improvement of depressive symptoms, the investigators are interested in examining the impact of this medication on vasomotor symptoms (hot flashes, night sweats), sleep and overall quality of life.

The menopause transition (or perimenopause) and the early postmenopausal years are marked by intense hormone fluctuations; hormone changes are frequently accompanied by the occurrence hot flashes, night sweats and sleep disturbance. Recent epidemiologic studies also demonstrate that perimenopause is a period of greater risk for the development of depressive symptoms.

To date, serotonergic antidepressants such as paroxetine and escitalopram have shown to be efficacious for the treatment of women with depression and menopause-related symptoms. We hypothesize that the use of quetiapine for this sub-population will alleviate symptoms of depression; we also anticipate that its use may enhance quality of life and improve vasomotor symptoms - the latter possibly due to quetiapine's effect on 5HT receptors and/or due to its sleep-promoting properties (e.g., by increasing the duration of total sleep time \[TST\], enhancing sleep efficiency, and decreasing the number of awakenings due to hot flashes).

Eligibility Criteria:
Inclusion Criteria:

* women 40 to 60 years
* diagnosis of MDD
* perimenopausal or postmenopausal

Exclusion Criteria:

* using HRT
* using psychotropic medications
* other DSM-IV axis I diagnoses other than MDD
The Effects of Selective Site Right Ventricular Pacing

This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing.

When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. What the investigators do not know is why this is the case.

Much effort has been directed at looking at features within the left ventricle (LV) for markers of disease progression but little has been investigated regarding the RV.

There may be some benefit to pacing the heart preferentially from different parts of the RV and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the RV.

Inclusion Criteria;

* Patients undergoing elective Electrophysiological Studies +/Ablation
* Age 18-80
* Normal Heart on Pre-procedural Echocardiogram

Exclusion criteria;

* Atrial Fibrillation
* Evidence of anterograde conducting accessory pathway
* Permanent Pacemaker insitu
* Pregnant
* Breast Feeding

Outcome Measures; Change in load-independent indices of LV and RV contractility before and after pacing intervention. LV and RV function measured by transthoracic echocardiography and tissue Doppler imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective Electrophysiological Studies +/Ablation
* Age 18-80
* Normal Heart on Pre-procedural Echocardiogram

Exclusion criteria:

* Atrial Fibrillation
* Evidence of anterograde conducting accessory pathway
* Permanent Pacemaker insitu
* Pregnant
* Breast Feeding
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.

To evaluate the safety and the dose-response of ASP1517 on hemoglobin (Hb) correction when ASP1517 is applied intermittently in dialysis chronic kidney disease patients with anemia.

To evaluate the treatment effect on Hb maintenance of ASP1517 administered intermittently in dialysis chronic kidney disease patients with anemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed as a end-stage kidney disease (ESKD) and are receiving stable chronic maintenance dialysis 3 times per week for ≥ 12 weeks
* Patients who are receiving ESA for at least 8 weeks and the dose of ESA is within the dose range of ESA label
* Hb value at screening test is ≥10.0 g/dL
* Receiving hemodialysis via arteriovenous fistula (AVF) or arteriovenous graft (AVG) or via permanent catheter
* Most recent two Hb values before dialysis during washout period must be both \<9.5 g/dL and one of two Hb values must be tested on first visit of the week

Exclusion Criteria:

* Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment
* Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, celiac disease, etc)
* Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or active gastroparesis
* Uncontrollable hypertension (SBP ≥160 mmHg and DBP ≥110 mmHg, before dialysis, at screening test)
* Congestive heart failure (NYHA classification III or higher)
* Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before 1st registration
* Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
* Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc)
* Pure red cell aplasia
* Using anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before 1st registration
Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake

The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.

Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.

During the " rest " session :

Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.

During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.

The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.

Eligibility Criteria:
Inclusion Criteria:

Overweight adolescents (over the 90 th percentile of the international cut-off point)

* With a computer and an internet connection
* Sedentary (according to the IPAQ-A questionnaire)
* Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

* Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
* Drugs that could interfere with the results of the study
* Surgical intervention in the 3 months
* Regular consumption of tobacco or Alcohol
* patients on a diet with caloric restriction
* Refusal to sign the consent form
* Regular practice of sport and intensive
Biospecimen Collection in Assessing the Effect of Trametinib With or Without Uprosertib on Biomarkers in Patients With Persistent or Recurrent Endometrial Cancer Enrolled on Trial GOG02290

This trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial GOG02290 with endometrial cancer that is persistent or has come back. Biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs.

PRIMARY OBJECTIVES:

I. To explore the impact of trametinib alone or in combination with uprosertib (GSK2141795) on RAF-MEK-ERK and PI3K pathway signaling.

SECONDARY OBJECTIVES:

I. To examine associations with early changes in functional proteomic biomarkers in tumor biopsies before and after treatment and tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.

II. To examine levels of circulating tumor cells in blood samples before and after treatment and correlate with tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.

III. To examine the bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in paraffin sections from these patients before treatment by proximity ligation assay (PLA) assays.

IV. To quantify exosomes from these patients before and after treatment by enzyme-linked immunosorbent assay (ELISA) assay with CD63 antibody and explore bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in exosomes from these patients before and after treatment by PLA assays.

OUTLINE:

Patients undergo collection of blood at screening, between days 3 and 5, 28, and 56. Patients also undergo collection of tumor biopsy at screening and day 28.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be enrolled on GOG0229O
* Patients must have tissue available for molecular analysis. This can be tissue obtained at time of current recurrence or archival tissue from primary diagnosis or recurrence
* Patients must have disease lesions that are amenable to pre- and post- treatment biopsy
* Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

* Patients unwilling to undergo a biopsy
A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA

This is a prospective, 3-year observational study to describe drug utilization in uninfected individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.

An electronic source of pharmacy/medical encounter information will be used to assess the demographics and other characteristics of the subjects prescribed FTC/TDF or its components in a prospective fashion. The data provider will supply all the de-identified information regarding each visit/interaction that the subject has had with the health system and all the diagnoses and medications that the UI has had prospectively and retrospectively for the length of time captured by the source selected.

200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same source.


Eligibility Criteria:
Key Inclusion Criteria:

* Patient/ Uninfected Individual
* Adult (any sex/gender, including transgender) ≥18 years old
* Taking FTC/TDF prescribed for any indication or its components Prescriber
* Possesses an active health care professional license in good standing, with the authority to prescribe prescription medications, either independently (eg, physician) or under legally permissible arrangements for prescribing under physician supervision (eg, Nurse Practitioner or Physician Assistant)
* Practice site is within the USA
* Having prescribed FTC/TDF for a PrEP indication

Key Exclusion Criteria:

* There are no exclusion criteria for individuals or prescribers

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.

PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.

OBJECTIVES:

I. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers.

II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery.

OUTLINE:

GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy.

GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients must generally be in good health with lab values and physical examination within normal limits
* Known high risk of breast cancer due to BRCA mutation or empiric risk \> 30% lifetime by the Claus model
* No evidence or history of pervious cancer, except non-melanoma skin cancer
* Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
* Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
* Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations
* Must be current non-smoker

Exclusion Criteria:

* GnRHA treatment within 12 months of study entry
* Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
* Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
* Pregnant or breast-feeding or have been so in the last six months
* Immeasurable breast density on mammogram
Computerized Tight Glycemic Control in Cardiac Surgery

The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.

Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia

Exclusion Criteria:

* under 18 years of age, or if patients had a premedical history of steroid therapy