cyrilzakka/clinical-trials huggingface dataset:
Short Course Radiation Therapy in Palliative Treatment

The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.

The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven locally advanced or metastatic H\&N cancer
* excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \< 3

Exclusion Criteria:

* prior RT to the same region.
Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction

vaginal electrical stimulation improves female sexual dysfunction


Eligibility Criteria:
Inclusion Criteria:

* women with complaint of sexual dysfunction at any part of sexual cycle

Exclusion Criteria:

* pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1 women with neurological disease and anatomical defect women with anatomical defect
Pilot Study on a Health Promotion Intervention for Ultra-Orthodox Mothers of Children With ADHD

The goal of this study is to evaluate the feasibility and effectiveness of a health promotion intervention for Ultra-Orthodox Jewish mothers of children with ADHD.

This study will examine the impact of a culturally tailored group-based intervention aimed at reducing stress, enhancing health, and improving the well-being of mothers.

The main questions this study aims to answer are:

1. Is the intervention feasible for mothers to participate?
2. Does the intervention improve maternal knowledge about ADHD and reduce stigma?
3. Does it help reduce maternal stress and enhance self-care practices?

Participants include:

Mothers: Ultra-Orthodox Jewish mothers with a child (ages 6-12) diagnosed with ADHD and no other major health conditions in the family (other than ADHD).

Educators: School educators with at least 5 years of experience teaching children with ADHD in the Ultra-Orthodox community.

What participation involves:

Mothers will attend six weekly teletherapy group sessions, with 6-8 mothers per group. They will complete questionnaires before and after the intervention (approximately 30 minutes each) and participate in a 90-minute remote focus group to provide feedback on the program.

Educators will attend a single teletherapy group session (90 minutes) during the program (session 5) and participate in a 90-minute remote interview to provide feedback on the program.

After providing informed consent, mothers will complete questionnaires which will take approximately 30 minutes before beginning the program. Mothers will then be assigned non-randomly to the intervention or control group. Mothers assigned to the control group will receive the intervention after the completion of the first intervention group (delayed).

The six sessions of the intervention will be teletherapy and each session will be one and a half hours in length. Each group will consist of 6-8 mothers per group.

Inclusion criteria included mothers who identify as ultra-orthodox Jewish, have a child between the ages of 6-12 years old who have been diagnosed with ADHD by a licensed medical professional, and who do not have any other medical diagnosis.

The topics discussed in the intervention will include: Awareness/knowledge regarding ADHD and its biological origins, Identifying resources and optimal treatment for ADHD for the child and the mother, Strategies for child ADHD management in the school, and the legitimacy and importance of maternal self-care.

Eligibility Criteria:
Inclusion Criteria:

* mothers of children with ADHD aged 6- 12 years old
* Mothers who identify as ultra-orthodox Jews
* Child diagnosis was by a licensed medical professional

Exclusion Criteria:

* Child medical diagnosis other than ADHD
Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening

The Centers for Disease Control and Prevention (CDC) recommends that emergency departments (EDs) and other health care facilities conduct HIV and HCV screening to identify and link to care those with undiagnosed infections. Screening for both infections in EDs is preferable due to: the shared overlap of some risk behaviors for HIV and HCV acquisition (e.g., drug use) the relatively high co-occurrence of these infections in some populations the more complex medical needs and worse sequelae for those co-infected, and efficiency. Although some EDs have experimented with dual HIV and HCV screening, best practices on how to conduct screening so as to maximize patient screening uptake have yet to be identified.

In this pilot RCT, the investigators will examine the efficacy of the persuasive health communication intervention in convincing adult ED patients who decline rapid HIV/HCV screening to be tested for these infections. Adult ED patients who decline rapid HIV/HCV screening will be randomly assigned to the ED medical staff arm or the HIV/HCV counselor arm. Within each arm, participants further will be randomly assigned to receive the persuasive health communication intervention or to watch a CDC HIV/HCV testing brochures-based video. Following the intervention or control condition, all participants will be offered rapid HIV/HCV testing again.

The investigators will conduct this R34 project at the Rhode Island Hospital ED, the primary site for many of the research team's previous HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) testing studies. Dr. Beaudoin (PI) is an attending physician at the Rhode Island Hospital ED. Our multi-disciplinary team consists of researchers with extensive experience in HIV and HCV testing research, intervention development and testing, and qualitative, quantitative and cost-effectiveness research.

First, the investigators will examine our primary objective in this R34 pilot RCT( Randomized Controlled Trial) of comparing the persuasive health communication intervention to the video. Second, the investigators can compare WITHIN study arms (HIV/HCV counselor arm, ED medical staff arm) and ACROSS these study arms uptake of HIV/HCV testing among participants. Second, the design permits the investigators to obtain initial efficacy data of the persuasive health communication intervention when used by HIV/HCV counselors vs. ED medical staff (ACROSS study arms), as well as compared to the video (WITHIN study arms). Third, the design replicates our subsequent R01 RCT when the investigators compare HIV/HCV screening uptake when conducted solely by HIV/HCV counselors vs. ED medical staff.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* English or Spanish speaking

Exclusion Criteria:

* HIV positive; HCV positive In an HIV vaccine trial
* On HIV pre-exposure prophylaxis medication
* In an HIV or HCV testing study
* Tested for HIV AND HCV within the past year (per EMR(Electronic Medical Record) review and patient report)
Hair Fall in Patients on Low Dose Methotrexate

Low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side effect profile very different from that seen with high dose methotrexate used in oncology. Hair fall has been found to occur in high dose methotrexate but there is no data regarding the same when methotrexate is used in low dose.Thus this observational case control study is being undertaken to determine whether rheumatoid arthritis patients really need to be concerned about hair fall when on low dose methotrexate.


Eligibility Criteria:
Inclusion Criteria:

For Cases

* Subjects should be above 18 years of age.
* Diagnosed with rheumatoid arthritis and fulfilling the ACR EULAR 2010 criteria.
* Should be initiated on methotrexate
* Willing to follow up

For Controls

-Subjects should be above 18 years of age.

Exclusion Criteria:

For Cases

* Subjects with prior exposure to methotrexate in the last 6 months
* Subjects suffering from Thyroid (hypothyroidism)
* Subjects on leflunomide, or having received leflunomide in the last 6 months
* Subjects currently on cyclophosphamide or having received cyclophosphamide in the last 3 months.
* Subjects on psychiatric treatment or depression illness.
* Subjects who have overlap with other rheumatological disorders which can cause hair fall.
* Subjects in 1-5 months of post-partum or post-natal period.
* Subjects with female pattern baldness
* Subjects with androgenetic alopecia
* Subjects with alopecia aereta
* Subjects with other scalp conditions which can predispose to hair fall

For Controls

* Subjects having any family history of alopecia.
* Subjects suffering from thyroid.
* Subjects having any history of anemia.
* Subjects under 1-5 months of post-partum or post-natal period.
* Subjects on medications which can cause hair fall.
* Subjects on methotrexate for other reasons.
* Subjects with female pattern baldness
* Subjects with androgenetic alopecia
* Subjects with alopecia aereta
* Subjects with other scalp conditions which can predispose to hair fall
Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056

The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis who completed study RA0056 (NCT01242488).

Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every two weeks, for the treatment of active rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed the RA0056 study (Week 12 Visit)
* Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of administration for at least 12 weeks
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
* Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 (olokizumab) dose
* Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038 (olokizumab)

Exclusion Criteria:

* Subject has an ongoing serious adverse event from the RA0056 study
* Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
* Subject has evidence of active or latent tuberculosis
* Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
* Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (\~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
* Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent adverse events) which in the Investigator's or Sponsor's judgment would make the subject unsuitable for inclusion in the study
Adaptive Cognitive Training on Cognitive Function in Elderly Diabetes Patients in the Community

Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairment of older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.

Participants Age 60 years or older, diagnosis of diabetes, fasting blood glucose≥6.1mmol/L and cognitive function assessment showed no dementia.

Design The study was designed as a double-blind randomized controlled trial. 120 diabetes participants without dementia aged 60 years or older in Shijingshan, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 6 months and follow up to 12 months, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to post-intervention, 6 months. The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (approval number: 2024-162).


Eligibility Criteria:
Inclusion Criteria:

* with a clear diagnosis of diabetes (according to ICD-10 or DSM-criteria), fasting blood glucose≥6.1mmol/L, maintaining the original diabetes treatment strategy
* age ≥60 years old
* literate and able to use smart phone or tablet computer skillfully, with CAIDE dementia risk score \>9, but without a diagnosis of dementia (ICD-10 or DSM-dementia diagnostic criteria)
* have lived in the target community for at least 6 months and continue to live in the original community for the next 12 months

Exclusion Criteria:

* Stroke or brain surgery in the previous 12 months
* Alcohol or drug abuse in the past 12 months
* Families, important people of participants in the study have concerns
* Live in the same household as a participant who has been randomly assigned
* Severe aphasia, physical disability, or any other factor that may prevent completion of neuropsychological testing
* Use of medications that may affect cognition, including sedatives, anxiolytics, hypnotics, nootropics, and cholinergic drugs; Refusing or not receiving cognitive training
* currently participating in another clinical trial.
Use of Muscle Ultrasound to Predict Function

Establish if change from the baseline in ultrasound muscle parameters over 2 months of rehabilitation correlates with functional status of SCI patients at the end of rehabilitation

Rehabilitation is the key to ambulatory recovery in patients with spinal cord injury, although only 25% of patients regain this ability despite current rehabilitation protocols. There is emerging evidence that intensive and prolonged rehabilitation, though costly and manpower intensive, may result in ambulatory recovery in patients previously thought to be non-ambulant. However, there are no suitable clinical biomarkers which can identify these group of patients who will benefit from this intervention.

Hence the aim is to establish if change from the baseline in ultrasound muscle parameters over rehabilitation correlates with functional status of SCI patients.

Eligibility Criteria:
Inclusion Criteria:

1. First ever acute SCI
2. Age 21-65 years
3. Presence of weakness in the lower limbs (defined as either ASIA A, B, C or D)
4. Independent in ambulation prior to onset of SCI
5. Able to understand study procedures and sign informed consent
6. Clinical suitability for rehabilitation

Exclusion Criteria:

1. Presence of premorbid lower musculoskeletal conditions eg contractures, fractures, previous operations, that prevents proper ultrasound assessment of the affected limb
2. Cardiorespiratory conditions eg congestive cardiac failure (EF\<40%), chronic arrhythmias, COPD stage 3-4
3. End stage illness, end stage renal failure, life expectancy \<6 months
4. Other active neurological conditions
5. Botulinum toxin injection over the past 3 months
Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2).

Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.


Eligibility Criteria:
Inclusion Criteria

* If patient: Graves' disease with positive TSH-receptor antibodies and thyroid hormones above the upper reference limit at diagnosis
* Diagnosis15 to 60 months ago. If recidive both episodes must have occurred within 15 months to 60 months.
* Thyroid hormones within normal range without anti thyroid drugs
* If control: No thyroid disease
* Patient and control without mental fatigue: Mental Fatigue Score ≤8 (cut off 10.5)
* Patient with mental fatigue: Mental Fatigue Score \>13 and debut of symptoms of mental fatigue in parallel with debut of Graves' disease, without other obvious cause

Exclusion Criteria

* Person unable to follow protocol
* Multiple sclerosis, myalgic encephalomyelitis/chronic fatigue syndrome, any other neurological disease
* Traumatic brain injury with unconsciousness
* Other disease strongly associated with fatigue
* Pregnancy and breast-feeding
* On-going or recent systemic treatment with steroids
* Radioiodine therapy within the last 18 months
Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes

Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?

Healthy collegiate athletes (football, soccer, rugby, hockey, and volleyball) will take Nicotinamide Riboside (NR) or placebo twice daily for 84 days. Pre- and post-intervention evaluations include physical assessment, blood tests for safety and toxicity monitoring, blood tests for biomarkers, neurologic testing, quality of life questionnaires, and the 31P MRI exam.

Eligibility Criteria:
Inclusion Criteria:

* Adult current and former (within 2 years) collegiate athletes (football, rugby, soccer, hockey, and volleyball)
* Body mass index (estimated based on height and weight) from 23 to 37
* Willing to provide informed consent, ingest test substance, and provide blood specimens
* Willing to comply with study instructions and maintain current level of physical activity throughout the study

Exclusion Criteria:

* History of loss of consciousness of more than 5 minutes
* Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal objects, or pacemakers
* History of epilepsy
* History of more than 3 concussions
* History of headache preceding a concussion
* History of depression preceding a concussion
* History of developmental delays or Attention Deficit Hyperactivity Disorder (ADHD)
* History of post-traumatic seizures
* History of complex spine and/or skull trauma
Standarization for Stappler Application During Sleeve Gastrectomy

Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the procedure, cutting of the stomach is performed with differents long of stapplers.

The aim of the study is to determine wich long of stappler is applicable in any stage of the procedure ans the variation expected.

After permormed laparoscopic sleeve gastrectomy the stonach retrieved for pathology study will be messured in three ponts: antrum, body and fundus.

In each point medition of the two walls and any wall (anterior and posterior) will be messurd.

Those data will be stariscally analized to perform a applicable guidelines for stapller selection.

Eligibility Criteria:
Inclusion Criteria:

* every laparoscopic sleeve gastrectomy
* between 18 y.o. and 70 y.o.
* no previous gastric operation

Exclusion Criteria:

* under 18 y.o. or over 70 y.o. previous gastric surgery
Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray

The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.

Participants will receive either the spray or cream prior to port access and rate pain on a scale.

Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy
* EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment
* Previous allergic reaction or skin irritation due to EMLA
* Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy

Exclusion Criteria:

* Child has a legal guardian or non-parent family member as the only adult with them for the visit.
* Children less than 4 years of age
* Children with altered mental status
* History of traumatic brain injury, developmental delay or autism
* Child is nonverbal
* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take effect.