cyrilzakka/clinical-trials huggingface dataset:
Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare this to the effect of sham DTMS on ADHD adults

Attention deficit disorder in adults may be due to hypoactivity of prefrontal areas of the brain. Increasing the activity of these areas may help improve symptoms in many of these patients. In addition there is evidence as to dysfunction in both hemispheres of the brain, but it is difficult to determine the contribution of each hemisphere's pattern of activity to behavioral impairment. The purpose of this study is to use high-frequency DTMS to stimulate activity either on the left side of the prefrontal cortex (one arm), or on the right side (a second arm), to see if such stimulation improves attention, comparing to sham DTMS simulation (a third arm).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-65.
* Appropriate diagnosis of ADHD according to DSM-IV criteria:

  o DSM-IV criteria require not only that the ADHD symptoms be present now (self-report), but also to have been present in childhood (self-report)
* Subjects taking medications for attention deficit disorder will give their consent to stop the drugs from a week before the start of participation in the study, and during the daily treatment phase (four weeks total); subjects also will be asked not to take these medications 24 hours before participation in the review meetings (4 and 8 weeks after the end of the daily treatment phase).
* Subjects have given their written and oral consent to participate in research.

Exclusion Criteria:

* Any DSM-IV Axis I psychiatric disorder.
* Use of antipsychotic stabilizers; other than benzodiazepines if necessary to a daily dosage equivalent to 2 mg Lorazepam.
* History of lack of tolerance to TMS.
* Diagnosis of severe DSM-IV personality disorder.
* Current suicidal tendency.
* Uncontrolled high blood pressure
* History of epilepsy, seizures or fever convulsions.
* History of epilepsy or convulsions in first-degree relatives.
* A history of head injury or a stroke which caused deficits.
* History of metal in the head (outside the oral cavity).
* History of plastic or metal implants, including metallic particles in the eye, pacemaker, implanted hearing aid devices, use of neurostimulators, or any medical pump.
* A history of drug or alcohol misuse.
* People who lack judgment or are unable to communicate with the experimenters.
* Participation in any other medical research during the three months prior to the time of this experiment.
* Subject's inability to sign a consent form.
* Pregnancy, or not using contraception.
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form
* Previously untreated participants with CD20-positive DLBCL
* Life expectancy ≥ 6 months
* IPI score 2-5
* ECOG Performance Status of 0, 1, or 2
* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
* Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows:

Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment ANC ≥ 1.0 x 10\^9/L PLT ≥ 75 x 10\^9/L

Exclusion Criteria:

* Contraindication to any of the individual components of Pola-RCHP or Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
* Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):

Serum AST and ALT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN Serum creatinine clearance \< 40 mL/min (using Cockcroft-Gault formula)

* Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
* Participants with a history of progressive multifocal leukoencephalopathy
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.

Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

1. Blood Urea Nitrogen \< 18.2 mg/dl
2. Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women
3. Systolic blood pressure ≥ 110 mm Hg
4. Heart rate \< 100 beats/min

Exclusion Criteria:

1. Inability to obtain informed consent
2. Pregnancy
3. History of liver disease
4. History of heart failure
5. Syncope that is temporally related to ongoing bleeding
6. Melena
7. Contraindication to proton pump inhibitor use
8. Other conditions that necessitate inpatient evaluation.
9. Inpatients with new onset of GI bleeding
Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02

RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future.

PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).

OBJECTIVES:

* Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years.
* Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD.
* Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.
* Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their time course correlates with BMD.
* Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome (disease-free survival). (exploratory)

OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured.

Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years.

Any surplus serum is stored for use in unspecified future research.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone
* Serial bone marrow density (BMD) measurements must be taken within the same institution
* Hormone receptor positive

PATIENT CHARACTERISTICS:

* See Disease Characteristics
* Premenopausal
* No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility
* No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease
* No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases
* No other bone disease (including osteomalacia or osteogenesis imperfecta)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as PTH or strontium)
* At least 6 months since prior glucocorticoid (\> 5 mg prednisone or equivalent) for \> 1 month
* At least 12 months since prior anticonvulsants
Inulin in Burn-induced Insulin Resistance

In this clinical trial, investigators will test the effects of dietary supplement inulin, on the reduction of insulin resistance developed as a result of burn injuryy.

As a consequence of burn injury, an exaggerated inflammatory response is developing in parallel with metabolic changes, which led to the development of hyperglycemia and insulin resistance. The post burn-injury insulin resistance is different in comparison to other trauma-induced insulin resistance. The main difference is the length. More precisely postburn-injury insulin resistance lasts longer than insulin resistance developed after other traumas. Insulin resistance can persist for years after the burn heals.

Inulin is a heterogeneous mixture of fructose polymers that are widely distributed in nature as storage of carbohydrates in plants. This mixture of fructose has nutritional value, but also affects general health, reducing the risk of developing various diseases. Inulin prevents gastrointestinal complications such as constipation, increases the resorption of minerals from the gastrointestinal tract, stimulates the immune system, and functions as a prebiotic, but can also affect insulin resistance in patients with metabolic syndrome.

The hypothesis: The everyday inulin can affect postburn-injury insulin resistance.

To investigate the effect of inulin on patients with postburn-injury insulin resistance a prospective, double-blind, randomized, and placebo-controlled clinical trial will be performed. This initial trial is a pilot trial. The pilot trial will be performed to assess the safety of treatment or interventions and recruitment potentials, examine the randomization and blinding process, increase the researchers' experience with the study methods and interventions, and provide estimates for sample size calculation for the main study.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent and willingness in study participation
* The age of the respondent greater than or equal to 18 years at the time of signing the informed consent
* Burns requiring in-hospital treatment
* insulin resistance detected on the fifth day of admission to the hospital

Exclusion Criteria:

* Documented pre-existing insulin resistance
* PCOS
* BMI ≥ 30 kg/m2
* Pregnancy
* Diabetes type 1
* Diabetes type 2
* Metabolic syndrome
* Use of drugs that can affect insulin resistance
* Weight loss greater than 10% in the last 6 months
Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients

Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery.

Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has shown an antioxidant property. The aim of the study is to compare the effects of propofol with desflurane on oxidative stress and inflammation markers in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>35
* scheduled gastric by pass surgery
* American Society of Anesthesiologists (ASA) \<III

Exclusion Criteria:

* Allergic to anesthesia agent
* patient refusal
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study

The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant arrhythmias in patients with NOP-LBBB following TAVI.

This is a prospective observational study including patients undergoing TAVI with either self- or balloon-expandable valves. After the procedure, patients will be on ECG monitoring during the hospitalization period (or at least 72 hours), and an ECG will be performed daily until hospital discharge in all patients. Patients with new-onset persistent LBBB at hospital discharge (new-onset LBBB of a duration of at least 48 h which persists at hospital discharge, at least 3 days and up to 15 days after the procedure) will receive an implantable loop recorder Reveal ICM LINQ®, which will be implanted subcutaneously to record adequate QRS complexes and P waves. The patients will be followed in outpatient clinic visits at 1, 12, 24 and 36 months after TAVR, or if symptoms suggestive of cardiac origin or relevant arrhythmic events occur. The device will be manually interrogated in each visit. Phone contacts will be also carried out every three months.

Eligibility Criteria:
Inclusion Criteria:

-Patients undergoing TAVI with either balloon or self-expandable valves who develop new-onset LBBB persistent at hospital discharge, at least 3 days after the procedure

Exclusion Criteria:

* Failure to provide informed consent
* Baseline pacemaker/defibrillator or pacemaker/defibrillator implanted during the hospitalization period following the TAVI procedure
* Pre-existing complete LBBB
* Patients with a life-expectancy of less than 2 years
The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients

This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.

Children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. They will start taking the product seven days before transplant starts until 14 days after transplant. Stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. Stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. They will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. From 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). No product (inulin or placebo) will be given during this time frame. The study period ends 100 days after transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Age 2-18 years
2. Allogeneic Stem Cell transplant
3. Myeloablative therapy
4. Inpatient at Lurie Children's Hospital

Exclusion Criteria:

1. Previous Hematopoietic Stem Cell Transplant
2. Autologous Stem Cell Transplant
3. Reduced Intensity Conditioning used for transplant
4. History of ulcerative colitis, Crohn's disease, irritable bowel syndrome, celiac disease
5. History of Type 1 or Type 2 Diabetes Mellitus
6. Previous abdominal surgery necessitating the use of an ostomy
7. G-tube dependence
8. Nasal gastric/oral gastric tube dependence prior to starting the conditioning process
9. Graft vs host disease prior to enrollment at any site
10. Children under 2 years of age - literature shows that the microbiome is still developing in children under two years of age, and this development may skew results
An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children at High Risk for Obesity

Children in rural communities experience significant obesity-related health disparities; they are 26%-55% more likely to be obese and less likely to have health insurance and access to weight management specialists than are their urban peers. Geographic-specific disparities in obesity may be due, in part, to variations in eating behaviors. Children in rural communities describe purchasing and consuming significantly more energy-dense, low-nutrient food items relative to their urban peers. Existing behavioral strategies for improving children's EI patterns have largely been ineffective in reducing risk for excess weight gain. The primary aim of the proposed study is to test the effects of a brief, novel strategy for improving rural children's eating behaviors. Specifically, the study aims to harness the well-documented benefits of an acute bout (20 min) of moderate physical exercise on children's executive functioning, and to see if these cognitive changes lead to better self-regulation of eating. If 20 min of moderate physical exercise is associated with observed improvements in preadolescent children's eating secondary to increases in executive functioning, these data may offer explicit targets for an obesity prevention trial in rural Oregon elementary schools.


Eligibility Criteria:
Inclusion criteria:

* 8-10 years (block recruited to ensure 50% female, 50% obese)
* Rural geographic location (≥ 10 miles from a city of ≥ 40,000)
* Understand English

Exclusion criteria

* BMI \< 5th percentile
* Major medical condition, current full-threshold psychiatric diagnosis, or moderate suicide risk (e.g., plan or intent)
* Current or recent use (\< 3 months) of medication known to affect body weight or energy intake
* Recent brain injuries that would be expected to affect neuropsychological functioning
* Mobility impairments that would impede their ability to walk on a treadmill
* Estimated full-scale intelligence quotient score ≤ 70
* History of pregnancy
* Significant food allergies that would prevent them from safely consuming the study's breakfast and lunch meals
* Responses on a food preference questionnaire that suggest that they do not like (i.e., rated them below 6 on a scale from 1 to 10) at least 50% of the food items offered in the lunch test meal
Assessment of Cancer Concerns at the End of Treatment (ACE)

This study will describe patient-reported symptom burden and concerns, quality of life (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider satisfaction following delivery of an electronic health record (HER)/EPIC summary of these PROs. Secondary aims will estimate differences in referral to available services between those providers exposed to the PRO summary and historical controls. BC survivors who have completed initial treatment and present within the first year following treatment for an end of treatment (EOT)/survivorship focused visit will be the focus of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with invasive, non-metastatic BC (Stage I, II, or III) without hematogenous or distant metastases
2. Have completed initial treatment (chemotherapy, radiotherapy, and/or surgery). May still be receiving hormonal or targeted therapy (e.g., tamoxifen, aromatase inhibitors).
3. Within 1 year of completing primary treatment
4. Scheduled for an EOT visit
5. Age 18 years or older
6. Can understand written English
7. Have internet access and a working email address

Exclusion Criteria:

1. Diagnosed with non-invasive (Stage 0/DCIS) or metastatic (Stage IV) cancer or hematogenous or distant metastatic disease
2. No working email address -
VOICES Socials for Older Veterans With Depression

VOICES Veterans Socials (VS) support Veterans in the community through weekly social groups. Veterans socials have the potential to improve social functioning, mental health symptoms, and create lasting social support. This project aims to evaluate and improve Veterans Socials to help older Veterans with depression by adapting materials, interviewing VS attendees, and collecting questionnaires. The goal is to improve the program based on the results for future use and research.

VOICES Veterans Socials is a peer-led weekly social group based in the community designed to promote sustainable social support among Veterans. The research seeks to adapt and conduct a preliminary evaluation of the Veterans Socials (VS) intervention with older Veterans. The study will develop a training procedure for VS facilitators and evaluate an open trial of this intervention. This study will determine whether a larger-scale, more definitive VS study is indicated

Phase 1: 13 total participants will engage in semi-structured interviews about barriers to social engagement, challenges around community-based activities, social support acquisition, and how their age and Veteran status intersects with these constructs.

Phase 2: 20 participants will be recruited for VOICES Veterans Socials (VS) which will be conducted in 2-4 community-based social groups, with 5-10 participants in each social group. The investigators will conduct data collection on three occasions; at enrollment (pre; 0 months), at intervention completion (post; including semi-structured interview; 4 months) and at follow-up (7 months).

VS Procedures. Twenty Veterans aged 65 or older with depression will engage in VS. Veterans will receive 90-minutes of weekly social engagement in a community-setting in accordance with the VS manual. Each week will focus on social connections, engagement in social activities, and reinforcing behaviors that give individuals meaning and purpose.

Eligibility Criteria:
Inclusion Criteria:

* Documented depressive disorder or score of 2 or more on the Patient Health Questionnaire-2 (PHQ-2)
* Capacity to consent as determined by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
* Score of 1 or more on question 3 of the UCLA-3 OR score of 3 or less on question 4 of the Lubben Social Network Scale 6 (LSNS-6)

Exclusion Criteria:

* DSM-5 diagnosis of Schizophrenia Spectrum Disorder or Bipolar Disorder
* Symptoms of psychosis that would interfere with study participation
* Probable Dementia as determined by the 6-item Cognitive Impairment Screener
* Suicidal ideation with plan or intent
* Non-English speaking
* Active substance use disorder (DSM-5) (within 30 days of study entry)