cyrilzakka/clinical-trials huggingface dataset:
Ear Electro-stimulation for Chronic Pelvic Pain

The Brigham and Women's Pain Management Center is conducting a research study for chronic pelvic pain patients due to endometriosis. The study will assess the effect of electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking opioid medication (such as morphine or oxycodone). The study will require two visits, each lasting about 2 hours. The study takes place at the Brigham \& Women's Pain Management Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or ccahalan1@partners.org if interested.

The Brigham and Women's Pain Management Center is conducting a research study for chronic pelvic pain patients due to endometriosis. The study will assess the effect of electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking opioid medication (such as morphine or oxycodone). The study will require two visits, each lasting about 2 hours. The study takes place at the Brigham \& Women's Pain Management Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or ccahalan1@partners.org if interested.

Vitaly Napadow, Ph.D., Lic.Ac. Assistant Professor Dept. of Radiology, Massachusetts General Hospital, Harvard Medical School

Eligibility Criteria:
Inclusion Criteria:

* Female volunteers between 21 and 64 years of age with chronic pelvic pain for more than six months by self report. Six months of chronic pain is the criteria most often used in CPP research.
* CPP diagnoses will include endometriosis pain.
* Average pain intensity of ≥4 on a scale from 0 to 10, because \<4 is considered a level with acceptable pain and function
* At least an 8th grade English-reading level; English can be a second language provided that the subjects feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Any interventional procedure for CPP two weeks prior to the study or during the two-week study period, such as lumbar epidural steroids, nerve root blocks, etc.
* Any etiology for CPP due to a known local somatic lesion for the pain (e.g. fibroids etc.) documented by the patient's gynecologist, surgery and/or imaging. We wish to focus on functional CPP, which may be more amenable to RAVANS due to the systemic nature of VNS.
* Opioid usage, either oral or intrathecal.
* Surgical therapy in the previous 12 weeks, the intent to undergo surgery during the study period, or any clinically unstable systemic illness that is judged to interfere with the trial.
* Non-ambulatory status
* History of cardiac or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
* An inability to complete questionnaires accurately.
* Cancer or other malignant disease, except carcinoma in situ of the skin
* Pregnancy
A Study of the Effect of Supervised Exercise Programme in Patients With Rheumatoid Arthritis

The purpose of this study is to compare the effectiveness of a supervised high-intensity exercise programme followed by an unsupervised exercise programme to an unsupervised exercise programme in patients with Rheumatoid Arthritis.

Patients with Rheumatoid Arthritis are in general less fit and more at risk of comorbidities such as cardiovascular events compared with healthy age-matched controls. Studies indicates that patients with Rheumatoid Arthritis have a lower level of physical activity than the general population and a low proportion of patients with Rheumatoid Arthritis exercises. Regular exercise with moderate to high intensity level of intensity has proven to be effective in reducing the cardiovascular risk by improving cardiovascular fitness and to increase muscle strength. Therefore, it is of interest to investigate if supervised exercise programme makes a difference making patients with Rheumatoid Arthritis participate in exercise.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Rheumatoid Arthritis within the last three years at Aarhus University Hospital according to the 1987 revised ACR criteria or the 2009 ACR/EULAR criteria
* must be able to sit on an exercise bike
* must be able to participate in 6-weeks exercise programme with training sessions twice a week at Aarhus University Hospital
* must be able to speak and understand danish

Exclusion Criteria:

* high disease activity assessed by DAS28-CRP
* Myocardial Infarction within the last six months
* Angina Pectoris
* treated with beta-blocker
* severe high blood pressure
* severe lung disease
A Feasibility Study of the SNUBY®, a Skin-to-skin Garment, in the Preterm Infant

Skin-to-skin care (placing the nappy-clad baby on the mother's bare chest and draping both in a blanket) is known to benefit both baby and mother. Benefits to the baby include warmth, reduced crying, and stabilisation of heart rate, breathing and blood sugar, and promotion of breastfeeding while simultaneously reduces mother's anxiety, improves bonding, and increases breastmilk production. Although these benefits are even more pronounced for preterm, studies show most preterm babies do not receive adequate skin-to-skin care due to fears such as dislodging intravenous lines, ventilation tubes, monitor wires and concerns about safety and privacy. Measures are therefore required to increase maternal confidence and awareness and facilitate skin-to-skin care for preterm infants.

SNUBY® (SNUggle baBY) is a purpose-built garment for facilitation of skin-to-skin care in preterm infants. It is made of comfortable, breathable bamboo fabric with an attractive appearance such that it can be worn as a normal garment.

In addition, it has distinctive features that allow the baby to be placed in a specially designed pouch, in direct contact with the mother's skin, with supports for lines and tubes that may be attached to the baby. Although many garments are commercially available for mothers to carry babies, no such specially designed garment has ever been tested scientifically and none are specifically designed for preterm babies. In this observational study, the investigators will initially test the feasibility of using the SNUBY® in preterm infants by inviting five mothers-preterm infant pairs, with mother's written informed consent, to use the garment under direct supervision. Following this, the investigators will analyse the safety and acceptability of using it on a larger scale to facilitate skin-to-skin care in preterm babies. The investigators will gather information on the staff and mothers' knowledge of skin-to-skin care and their experience of using SNUBY®.

Skin-to-skin contact is used as part of a package of Kangaroo Mother Care across the world. This has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for low birth weight and preterm infants (Charpak and Ruiz 2016).

This study examines the effect a facilitating garment, the Snuby® has on neonatal health outcomes associated with skin-to-skin contact, such as neonatal thermoregulation, breastfeeding status, and self-reported mother-infant bonding. It uses a mixed methods approach to address quantitative and qualitative outcomes including participant's perspectives, and measurable health markers.

Eligibility Criteria:
Inclusion Criteria:

* Preterm (born at \< 37 weeks gestation) infants
* Admitted to the Neonatal Intensive Care Unit
* Well enough to receive skin-to-skin care
* Mothers who agree to participate AND Mothers of eligible preterm infants

Exclusion Criteria:

\*Any infant or mother considered unsuitable for skin-to-skin care for medical reasons (as decided by the attending Consultant Neonatologist).
Special Survey Long-term Treatment With Tiotropium on COPD

Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of Chronic Obstructive Pulmonary Disease
2. Patients were expected to use the product for long period of time

Exclusion Criteria:

1. Patients with glaucoma
2. Patients with micturition disorder due to prostatic hyperplasia etc.
3. Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product
Near Fatal Asthma in Children and Young People

This study will report the frequency, risks factors, clinical care and estimate the future asthma risk of children and young people (aged 5-15 years) experiencing a Delphi defined near fatal asthma (NFA) attacks in the United Kingdom (UK) and Republic of Ireland (ROI). A greater understanding of the frequency and risk factors associated with NFA could help support children and young people (CYP), parents and clinicians to identify and modify risk, both independently and through a resulting clinical care pathway and also develop future research to improve effectiveness of interventions. The study will explore both commonly identified clinical factors, but also for the first time describe in detail the variance in medical management (acute and intensive care) that could lead to future clinical trials and guideline development to standardise care. The study will also describe, through data-linkage, socio-demographic factors associated with NFA, to include pollution, pollen, weather, viral prevalence that could lead to better care for higher risk CYP.

To encourage more consistent, less fragmented care following a near fatal asthma attack, the study will consider how care is provided subsequent to an NFA attack using British Paediatric Surveillance Unit (BPSU) surveillance at 12 and 24 month follow up.


Eligibility Criteria:
Inclusion Criteria:

* A child/young person is considered to have experienced an episode of near fatal asthma if they meeting any one of the following:

  1. Any child aged 5-15 years surviving\* an acute episode of asthma, who when presenting self-ventilating with severe dyspnoea (e.g. inability to speak) and all the following features:

     1. Pulse oxygen saturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via non-rebreather mask) during acute presentation
     2. pH \<= 7.2 and/or pCO2 \>=60mmHg or 8kPa
     3. Escalation to use of intravenous bronchodilator infusion
  2. Any child aged 5-15 years surviving\* an acute episode of asthma, who had a respiratory arrest and/or required cardiopulmonary resuscitation as part of their presentation.
  3. Any child age 5-15 years surviving\* an acute episode of asthma for which he/she was invasively ventilated.

     * surviving to hospital discharge

Exclusion Criteria:

* CYP not meeting the case definition will be excluded. An expert panel (consisting of three clinicians) will adjudicate borderline cases.
Study of Modified Atkins Diet in Kabuki Syndrome

Animal models of Kabuki syndrome have showed a reversal of the cognitive phenotype with ketogenic diet. Modified Atkins diet is safer and easier tolerated than full ketogenic diet and still has the histone deacetylase inhibition believed to be responsible for the cognitive improvement. This study aims to examine a small number of adults with Kabuki syndrome before and after 12 weeks on a modified Atkins diet to determine if there is any cognitive improvement and if the diet can be tolerated.

Consented participants will participate in an initial 2 day study visit. These participants will undergo cognitive and neurobehavioral testing and also will have baseline labs drawn and will meet with a Johns Hopkins nutritionist trained in modified Atkins diet for education. The labs are standard of care for diet initiation to rule out contraindications to the diet. Participants and/or their caregivers will keep a daily diet log and will be asked to download the free Carb Manager application onto their smartphone. They will send the logs and data back weekly. Participants will be given urine ketone strips and asked to use and record in their diet log twice weekly. Participants will have blood and urine samples collected locally every 3 weeks and sent back to study team to measure Beta-hydroxybutyrate, metabolic studies and methylation. Participants will return to Baltimore at the end of 12 weeks for a one day visit to repeat the cognitive assessment protocol, neurobehavioral measures, and repeat the initial and follow up lab tests.

Eligibility Criteria:
Inclusion Criteria:We will recruit 15 total participants with clinically-definite and genetically-confirmed Kabuki syndrome type 1 age 18 years and older. . will also be required.

* Clinical diagnosis of KS will be made based on recently published consensus diagnosis criteria
* Genetic confirmation of a pathogenic mutation in KMT2D

Exclusion Criteria:

* presence of another known genetic syndrome
* a health problem that would make a modified Atkins diet harmful
* inability to travel to Baltimore for 2 visits separated by 12 weeks
Study of Aripiprazole to Treat Children and Adolescents With Autism

The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
* Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
* Have a guardian who is able and willing to give written informed consent
* If competent, subject able and willing to give written assent for their own participation
* If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
* Subjects may receive other nonpharmacologic treatment including dietary treatments

Exclusion Criteria:

* Diagnosis of Rett's syndrome or Child Disintegrative Disorder
* Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
* Previous trial of aripiprazole
* Pregnant or nursing
* Epilepsy or another significant chronic medical illness
Liver Status in Psychiatric Inpatients

Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease).

The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients.

The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology

The LIVERSPIN study aims to estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.

All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Social insurance
* Current hospitalization in any psychiatric unit of the participating center
* Adult or legal representative who has given written and informed consent to participate in the study. By default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative)
* Information given to the curator(for people under curatorship)

Exclusion Criteria:

* - Clinical state of the patient which do not allow the collection of study data (according to the investigator)
Adenosine as an Adjunct to Blood Cardioplegia

Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive, port access operations (mitral valve surgery).

Half of the participants will receive standard intermittent warm blood cardioplegia, while the other half will receive intermittent warm blood cardioplegia enriched with adenosine.

Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T (cTnT) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgical patients

  * minimally invasive, port access surgery (mitral valve surgery)

Exclusion Criteria:

* All non-minimally invasive, port access surgery
* Theophylline or dipyridamole use up to 24 hours prior to surgery
* Products that contain caffeine of theobromine up to 12 hours prior to surgery (coffee, chocolate, energizing drinks (e.g. Red Bull), tea, soda (coke), etc)
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer

RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread.

PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.

OBJECTIVES:

* Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
* Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.

OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.

At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
2. Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
3. Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
4. Patients must sign an informed consent and be registered before the procedure is performed.

Exclusion Criteria:

1. A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
2. Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
3. Patients with known allergy to isosulfan blue dye or any related compounds.
Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients

The goal of this clinical trial is to assess the use of a generative artificial intelligence large language model chatbot in improving decision making factors in patients with hip and knee osteoarthritis. The main questions it aims to answer are:

Does the use of an artificial intelligence chatbot have an effect on decisional conflict and anxiety related to decision making? Are changes in decisional conflict correlated with changes in patient reported outcomes? Are changes in decisional conflict correlated with health literacy? Participants will interact with an artificial intelligence chatbot prior to their clinic visit with an orthopaedic surgeon, using a structured prompt.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Ability to read and write in English
* All races and ethnicities
* Clinical symptoms of hip and/or knee osteoarthritis

Exclusion Criteria:

* Inability to read and write in English