cyrilzakka/clinical-trials huggingface dataset:
Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation

RATIONALE: Light-emitting diode (LED) therapy may be able to prevent mucositis of the mouth.

PURPOSE: Randomized phase II trial to determine the effectiveness of LED therapy in preventing mucositis of the mouth in children who are receiving chemotherapy with or without radiation therapy before donor bone marrow transplantation.

OBJECTIVES:

* Compare the incidence and severity of oral mucositis in children undergoing NASA-developed light-emitting diode (LED) therapy during a pre-transplantation myeloablative conditioning regimen (chemotherapy with or without radiotherapy) and continuing through the post-bone marrow transplantation (BMT) phase versus LED therapy during the post-BMT phase only.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center and cheek being treated (right vs left). Patients are randomized to 1 of 2 schedules of light-emitting diode (LED) therapy.

* Arm I: Patients undergo LED therapy for 71 seconds once daily beginning on day 1 of the myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy and continuing for 14 days after bone marrow transplantation (BMT).
* Arm II: Patients undergo LED therapy as in arm I beginning on the day of BMT (day 0) and continuing for 14 days after BMT.

Photographs are taken of the right and left buccal mucosa at baseline and then every 3 days beginning on day 1 of LED therapy.

Pain and xerostomia are assessed using the Wong-Baker "smiley-face" pain scale at baseline and then periodically for 14 days after BMT.

Patients are followed monthly for 2 years.

PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients undergoing a myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy prior to a first allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

* 2 to 18

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Pulmonary:

* No pulmonary dysfunction that would increase significantly the risk of requiring intubation during the first 21 days after transplantation

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No photophobia
* Must have emotional, cognitive, and mental maturity sufficient to tolerate light-emitting diode therapy application and oral examination without combativeness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* Not specified

Other:

* No concurrent medication that may cause epidermal or ocular photosensitivity
Mechanical Versus Manual Cardiopulmonary Resuscitation

In this study, the investigators compared mechanical and manual chest compressions in in-hospital cardiac arrest cases.

In this study, the investigators analyzed cardiopulmonary resuscitations performed over a 2-year period in an emergency department of a training and research hospital and compared success of manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge. Investigators present the study as an in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases included in the study were performed in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

Over 18 age Cardiac arrest cases In-hospital cardiac arrest cases Resuscitations performed in emergency department

Exclusion Criteria:

\<18 age
Avoiding Diabetes After Pregnancy Trial

The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the effectiveness of interventions that potentially increase the adoption of Diabetes Prevention Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).

The study was conducted as an integrated trial with two separate arms: one to facilitate weight reduction and the other to increase diabetes testing.

There were two hypotheses:

1. Women in the testing intervention will be more likely to have received a diabetes test within the 6 months post-intervention than women in the control group.
2. Women in the weight reduction intervention will have lost more weight at the 6-month and 9-month follow-up than women in the control group.

The primary study aim was to determine the efficacy of a system of interactive technology-based supports to prompt women with a history of gestational diabetes to take steps to prevent diabetes. The secondary aims were focused on women's engagement:

* To evaluate the impact of the weight reduction intervention in terms of participant engagement with the interactive technology-based supports.
* To evaluate changes in the women's perception of their personal diabetes risk following after exposure to information about diabetes risk following a pregnancy with GDM.
* To identify the determinants and motivators of and barriers to diabetes testing in the 6- to 12-week postpartum period and thereafter, using the Health Belief model to guide the study.

There was an additional secondary aim involving metformin:

* To evaluate the impact of the diabetes risk reduction intervention in terms of women seeking out their physician's advice on metformin treatment and receiving a metformin prescription, if appropriate.


Eligibility Criteria:
Inclusion Criteria:

General

* History of GDM in the previous 6 months to 4.5 years
* Access to the internet and text messages or phone messages
* Current patient of Harvard Vanguard Medical Associates
* 18 years of age or older
* Able to read in English

Weight Reduction Group

* Overweight or obese
* Capable of performing moderate physical activity

Diabetes Testing Group

* Had not competed a diabetes test (OGTT or fasting blood sugar at 6-12 weeks postpartum or OGTT, fasting blood sugar or hemoglobin A1c after 12 weeks postpartum)

Exclusion Criteria:

General:

* Diabetes diagnosis
* Psychotic disorder diagnosis
* Enrolled in a research study

Weight Reduction Group

* Taking prescription medications for weight loss
* Engaged in a formal weight reduction program

Diabetes Testing Group

* History of postpartum OGTT, fasting plasma glucose or hemoglobin A1c (after 6 weeks postpartum)
PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter Coupled With Oral Vitamin D Supplementation vs. Placebo

Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients

The major therapeutic challenge in patient with Atopic Dermatitis is long-term control of disease activity (LTC), for which the current TAT-based pro-active strategy does not meet all the needs.

Phototherapy is a good candidate: it is widely used as a second-line treatment in AD with demonstrated efficacy. However, only short-term control has been evaluated; and only 2-3 times a week intensive schedules have been tested and are used in current practice. A novel phototherapy regimen would be required for disease LTC, allowing a trade-off between disease control, UV-induced risks, and patient adherence.

Vitamin D supplementation is another good candidate: several studies have shown lower serum levels of vitamin D to be correlated with more severe AD; and three short-term, low-power low-quality, placebo-controlled randomised trials testing vitamin D supplementation yielded conflicting results, leaving its therapeutic efficacy undecided for short-term control, and unknown for LTC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atopic dermatitis (Hanifin and Rajka criteria),
* Aged 15 years or more,
* With \> 2 years of disease evolution,
* With moderate-to-severe disease (IGA \> 2),
* Patients that have received TAT for at least 12 weeks and have symptoms requiring an increase in therapy,
* Seasonality in disease severity (based on a questionnaire assessing disease improvement during summer),
* Easy access to a phototherapy cabin (widely implanted in primary care dermatology private practice in France),
* Effective contraception to be used at least 30 days before initiation of treatment, during treatment and 29 weeks after last administration for women of reproductive age,
* Written informed consent of the patient
* For patients aged between 15 and 18, written informed consent of the parents and of the teenager.

Exclusion Criteria:

* Any cause of contra-indication for vitamin D supplementation: flare of granulomatosis, primary hyperparathyroidism,
* Clinical suspicion of hypercalciuria,
* Indication to a systemic immunosuppressant in the next 2 years,
* Atopic dermatitis known to be aggravated by UV exposure,
* Any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of personal skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication (see appendix 2),
* More than 100 previous phototherapy sessions in lifetime,
* Pregnancy or breastfeeding,
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients

The prevalence of obesity in Spain is about 21.6%. The discouraging results provided by dietary treatment, together with the lack of funding for pharmacological treatment, have led to the progressive use of bariatric surgery (CB). Besides weight loss, CB associates a beneficial effect on metabolic comorbidities. However, 25-30% of operated patients present a weight response considered inappropriate, they do not resolve their comorbidities and/or present a weight-regain shortly after surgery. Therefore, predictive strategies are necessary to allow a correct selection of obese patients who are candidates for CB.

The main hypothesis of the study is that various factors such as psychopathological profile, body composition and metabolic alterations related to morbid obesity can influence the response to bariatric surgery.

The investigators have designed a prospective study in which 200 consecutive patients from the outpatient clinic of the Morbidly Obesity Unit of the Vall d'Hebron Hospital will be included, meeting criteria for bariatric surgery (with BMI\> 40 kg / m2 or BMI\> 35 kg /m2 in the presence of comorbidities) and will undergo surgery in the investigator's center between September 2018 and September 2019. All patients will undergo (baseline, month, 6, 12 and 24 month): complete clinical history, analysis complete biochemistry, 2 blood samples will be extracted to study metabolomics, stool sample for microbiota study, bioimpedance for the study of body composition, determination of AGEs in the skin and lens, cognitive function assessment, retinal function assessment by microperimetry and they will be asked to complete several specific questionnaires for the evaluation of the psychopathological profile and the dietetic survey.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling criteria for bariatric surgery (BS).
* Signed informed consent fir the BS and the study.
* Previous accomplishment of the preoperative protocol for the BS at our site.
* undergo BS between September 2018 and December 2019
* Able to read and understand the specific questionnaires.

Exclusion Criteria:

* Any contraindication for the bariatric surgery.
* Impossibility to follow-up at our site (eg: patients from outside out community).
Erector Spinae Plane Block in Renal Transplantation Donors

Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid consumption in postoperative period on donor patients who will undergo laparoscopic nephrectomy in renal transplantation surgery will be examined prospectively.

The aim of the study is to provide analgesia to donor patients using less opioids by Erector Spina Plan Block and provide enhanced recovery.


Eligibility Criteria:
Inclusion Criteria:

* Donor patients scheduled for elective nephrectomy in renal transplantation surgery
* ASA I-II
* Patients who are aged between 18-75

Exclusion Criteria:

* Skin infection at the Erector Spina Plan Block area
* Coagulation disorder or using anticoagulant drugs
* End-stage organ and system failure
* Severe pulmonary and/or cardiovascular problems
* Substance addiction or known psychiatric or mental problems
* Chronic painkiller usage
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.

Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT.

Hypothesis: Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed. They will also report less ear pain once at pressure compared to patients receiving placebo.

Aim 2: To measure the incidence of MEB during HBOT. The investigators will also identify factors (age, gender, medical history) that could predispose an individual to developing MEB during HBOT.

Hypothesis: The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30%. Female sex, age above 60, and prior history of ear conditions will be associated with development of MEB.

Eligibility Criteria:
Inclusion Criteria:

* New patient requiring HBOT (either inpatient or outpatient)
* Age greater than or equal to 18 years and less than 80 years
* Fluent in English
* Full decision capacity
* Able and medically cleared to swallow a pill

Exclusion Criteria:

* Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to drug class)
* SBP \>160
* DBP \> 90
* HR \>100
* Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
* Prisoner
* Intubated
* Unable take PO meds
Molecular Determinants of Persistent Cancer Related Fatigue

The purpose of this study is to determine if inflammatory markers in blood as well as brain neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or chronic fatigue.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

- Women age 18 or older with no contraindication to magnetic resonance imaging(MRI);

Fatigued BC Participants:

* Have a diagnosis of breast cancer;
* And have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and or herceptin at least 12 weeks previously; and be apparently cancer-free.

Age-Matched, Healthy Participants:

* Generally healthy;
* Matched in age ± 2.5 years to a Fatigued BC participant.
* No prior history of any cancer except for basal cell or squamous cell tumors of the skin that have been surgically excised;
* Have good sleep quality
* Have no chronic pain
* Have no chronic fatigue

Exclusion Criteria:

* Pregnant, wanting to become pregnant or lactating women ;
* Diagnosed with anemia \[defined as hemoglobin levels \< 12 gm/dl\] or receiving treatment for anemia ;
* Diagnosed with any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure)
* Diagnosed with nutritional deficiencies;
* Have a diagnosis of untreated hypo- or hyper-thyroidism
* Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study;
* Have implanted (e.g., surgical clips or staples) metal objects.
The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and non-pregnant women between the ages of 18 and 55
* Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Baseline ADHD score of at least 24

Exclusion Criteria:

* Weight less than 100 pounds or greater than 250 pounds
* Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
* Pregnancy or breastfeeding
* History of seizures
* Positive urine drug screen
Patient-Centered Advance Care Planning

Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.


Eligibility Criteria:
Inclusion Criteria:

* At high risk for impending death in the next 12 months

Exclusion Criteria:

* Patient not having decision-making capacity
Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages

For implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. We have found a combination of maternal immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia where placenta does not implant adequately. The aim of this research is to investigate these two genes family in women suffering with recurrent miscarriages and find a possible link between them.

Little is known about reasons for early pregnancy failures. It is believed that some pathology leading to defective implantation of fetus in maternal uterus may lead to recurrent early miscarriages. This project arises from previous work on pre-eclampsia where we found combination of maternal immune genes (KIR) with their ligand (HLA-C) in the fetus was strongly associated with the disease. We will tissue type the fetus, mother and father in cases of unexplained miscarriages. We hope that genetic findings in recurrent miscarriage will lead to new insights, prevention and treatment.

Eligibility Criteria:
Inclusion Criteria:

Couples with 3 or more unexplained miscarriages

Exclusion Criteria:

Previous livebirths, parental karyotypic abnormalities, thrombophilic defects, uterine structural abnormalities
The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. The measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. The macular thickness measurements before and after injection were compared.

Eligibility Criteria:
Inclusion Criteria:

* Having diffuse diabetic macular edema persisted at least 1 month
* No intravitreal injection in last 3 months.
* No retinal laser photocoagulation in last 6 months
* Not have any other macular disease causing macular edema

Exclusion Criteria:

* Having ischemic macula
* Intravitreal injection in last 3 months.
* Retinal laser photocoagulation in last 6 months
* Have any other macular disease causing macular edema