cyrilzakka/clinical-trials huggingface dataset:
Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Allogeneic hematopoietic stem cell transplantation (allo-HSC) is currently one of the only curative treatments for haematological malignancies with a poor prognosis, the realization of which presupposes the identification and availability of a compatible donor. In recent years, haploidentical transplants have been developed, a reliable alternative for patients who do not have 100% compatible donors.

The development of haplo-identical transplants leads to an exponential increase in the use of intra-family donation. Intrafamilial donation of hematopoietic stem cells (HSC) has the advantages of lower financial cost and faster availability of the graft, thus avoiding the risk of relapse before the procedure. Nevertheless, intrafamilial donation raises clinical and ethical questions. Indeed, the psychological impact of intra-family donation on the donor cannot be overlooked. Thus, in the context of the development of haplo-identical transplants, measuring the impact of donation on donors (ascendants and descendants) will make it possible to assess the relevance of taking psychosocial aspects into consideration in the choice of donors, to assess the psychological impact of haplo-identical donation and to offer psychological support adapted to donors.

This is a prospective, exploratory and bicentric study with a quantitative and qualitative approach, with the aim of exploring the psychosocial aspects of the experience of haplo-identical transplantation in adult HSC donors for transplantation. haplo-identical for their children or for their parents.

For this, the evolution of the anxiety and depression) of the donors will be evaluated on D0, D90, D180 and D360 post donation, thanks to State-Trait anxiety Inventory questionnaire, Center for Epidemiologic Studies Depression Scale and by the 12-Item Short Form Health Survey;

Eligibility Criteria:
Inclusion criteria:

* Identical haplo CSH donors ascending (parents) or descending (children)
* Major identical haplo HSC donors
* Haplo-identical HSC donors living in mainland France and cared for in the centers participating in the study
* Haplo-identical HSC donors benefiting from Social Security System.
* Haplo-identical HSC donors who have signed the consent form
* - Ability to read and write in French

Exclusion Criteria:

- Insufficient understanding of the French language
Comparison of Primovist-enhanced MRI, Diffusion Weighted MRI and Multidetector CT of Colorectal Liver Metastases

1. Primovist-enhanced Magnetic resonance imaging (MRI) and Diffusion Weighted MRI (DW-MRI) is superior to Multidetector Computed axial Tomography (MDCT) in the detection of colorectal liver metastases. Fatty changes in the liver after chemotherapy treatment likely reduces the chances of seeing metastatic lesions on CT especially when the lesions are small (\<10 mm). When compared with CT, Primovist-enhanced MRI and DW-MRI have the potential to provide higher contrast resolution enabling better detection of colorectal liver metastases following chemotherapy.
2. Primovist-enhanced MRI and DW-MRI are superior to CT in assessing and predicting treatment response of patients with colorectal liver metastases to chemotherapy. Primovist-enhanced MRI by providing superior resolution may provide improved accuracy in metastatic lesion margin detection thereby providing higher accuracy in estimating tumor response based on size criteria. DW-MRI provides information indirectly about tumor composition and therefore is likely to be superior to MD-CT in assessing treatment response.

Two groups of patients will be analyzed. The second group consists of patients with colorectal liver metastases who are to go for chemotherapy prior to surgery for metastases resection. This group will be CT and MRI scanned prior to chemotherapy and after chemotherapy. The first group of patients will consist of those patients who have already received chemotherapy and are likely to have surgery to resect liver metastases. This group will have only one set of scans done 4-6 weeks prior to their operation. The pathology of the resected metastases and CT and MRI images will be analyzed and compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal liver metastases already treated by chemotherapy and scheduled for surgical resection
* Patients with colorectal liver metastases scheduled to receive chemotherapy with possibility of future liver resection.

Exclusion Criteria:

* Acute or Chronic Renal Disease with Estimated GFR (eGFR) \<30 mL/min.
* Hypersensitivity to MRI contrast or CT contrast or to any ingredient in the formulation or component of the container.
* Patients with: acute or chronic severe renal impairment (glomerular filtration rate \<30 mL/min/1.73 m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
* General contraindications to MRI such as pacemaker or ferromagnetic implants.
* Severe cardiovascular problems
* Pregnant or nursing women
* Age \<18 years
* Liver Surgery is not a possibility.
Sound and Music for Mild Cognitive Impairment

Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Community-dwelling
2. amnesia mild cognitive impairment
3. Preserved function
4. No dementia

Exclusion Criteria:

1. known diagnosis of schizophrenia or Parkinson's disease;
2. severe hearing impairment;
3. presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically
Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.

In vitro and clinical researches using Punica granatum Linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. The purpose of this study was to evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm and gingival inflammation in school children

Eligibility Criteria:
Inclusion Criteria:

* Age group: 09-12 years old
* Presence of at least 20 teeth
* Simplified Oral Hygiene Index (S-OHI)≥ 1,6

Exclusion Criteria:

* Use of orthodontic appliance
* Recent (in the past 2 months)use of antibiotics and mouthwashes
Clinical Trial of Concomitant Hip Arthroscopy During PAO

The study will assess the outcomes of patients treated with concomitant hip arthroscopy at the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with patients treated with PAO alone.

There are currently no absolute indications for intraarticular assessment at the time of periacetabular osteotomy (PAO). Based on investigators' review of the literature and experience, patients who may benefit from intraarticular assessment are those with radiographic or MRI evidence of damage where an intraarticular inspection may help in determining whether a PAO is a reasonable procedure, those with mechanical symptoms likely related to labral pathology, round ligament or cartilage problems and those with hip dysplasia and cam deformities with limited range of motion that may benefit from femoral head neck junction osteochondroplasty. However, despite these relative indications today there is no clear evidence to suggest that these patients will do better than those that do not have intraarticular work done. Hence, the objective of this project is to determine whether intraarticular work at the time of PAO surgery leads to improved pain and function when compared to patients that do not undergo intraarticular work at the time of PAO.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment
* Skeletally mature
* Age 15 - 55
* Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
* Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip

Exclusion Criteria:

* Pregnant women
* Previous surgery about the hip
* Patients receiving PAO for acetabular retroversion in the absence of DDH
* Previous hip arthroscopy to address intra-articular pathology
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project

GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP) or 2) a tailored telephone-based counseling and navigation intervention (TCN). Post-award, the target sample size was revised to (n=642) with NIH permission.

There is increasing evidence that activated and engaged patients who are equipped with necessary skills and information are more likely to follow through with recommended care and have better health outcomes at reduced costs. Identification of individuals at increased risk of hereditary breast and ovarian cancer (HBOC) is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. The primary purpose of this study is to assess the feasibility and acceptability of two remote interventions aimed at promoting cancer genetic risk assessment (CGRA) for HBOC. The randomized controlled trial will have 3 arms: usual care (UC) vs. targeted generic print (TP) vs. tailored telephone counseling and navigation intervention (TCN).

Eligibility Criteria:
Inclusion Criteria:

Breast Cancer

* Hispanic or non-Hispanic
* Female
* 21 years of age or older
* English-speaking
* Breast cancer history

  * breast cancer at the age of 50 or younger OR
  * triple-negative breast cancer OR
  * two or more primary breast cancers

Ovarian Cancer

* Hispanic or non-Hispanic
* Female
* 21 years of age or older
* English-speaking
* History of ovarian, fallopian, or peritoneal cancer diagnosed at any age

Exclusion Criteria:

Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
COVID Card Pilot Study to Detect Antibodies to SARS-CoV-2

This study aims to investigate the clinical performance characteristics of the novel point-of-care, semi-quantitative test for SARS-CoV-2 in the Emergency Department compared to the gold standard (ELISA).

A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland.

Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information and past medical history. Upon enrollment into the study, a study team member will obtain a fingerstick blood sample and a sample of blood obtained during usual care venipuncture. Both fingerstick blood and blood from venipuncture will be run on the point-of-care, semi-quantitative test. The test should be expected to result within minutes after the blood sample is added to the agglutinin. An additional tube of blood will be obtained and sent to the local central laboratory for quantitative serum SARS-CoV-2 antibody testing.

Additional data will be collected on the reported or documented COVID-19 immunization status and reported or documented history of prior COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age \> 18 years) emergency department patients
2. ED workup includes blood testing
3. Confirmed history of vaccination against SARS-CoV-2

Exclusion Criteria:

1. Known to be pregnant at the time of evaluation
2. Incarcerated at the time of evaluation
3. Requires the use of an interpreter
4. Patient is considered immunocompromised or has any other condition that the investigator feels makes the patient unsuitable for study inclusion.
5. Has any other condition that the investigator feels makes the patient unsuitable for study inclusion
Music and Physical Activity in Persons With Dementia

Fronto lobe dementia constitutes 10-20 % of dementia conditions within younger persons (\>65). People with neuronal degeneration in frontal and temporal lobes demonstrate a decline in social conduct, apathy, loss of insight that is gradual and progressive. Family members often experience guilt and shame because of the patients' behavior before institutionalization, and different behavioral disorders will cause great challenges to family caregivers and to staff after institutionalization. Preservation of dignity, both in regards to the person being affected, and their relatives, therefore seem highly relevant both before and after institutionalization.

The purpose of this study was to evaluate whether a combined intervention of physical activity and music therapy could reduce restlessness, irritability, and aggression among institutionalized people with severe dementia. An exploratory design was used to evaluate a combined intervention of physical activity, music therapy, and in- or outdoors walking daily, systematically implemented for eight weeks for persons with severe dementia in institutional care.

Eligibility Criteria:
Inclusion Criteria:Persons with dementia with symptoms of frontal lobe dementia, who had lived for at least 6 months in a unit special care dementia unit in a nursing home

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Exclusion Criteria:

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The Impact of the Certified Child Life Specialist on Children's Pain During Immunizations

The purpose of this study is to provide the first systematic evidence that Certified Child Life Specialists reduce pain during vaccine administration and improve caregiver visit satisfaction in the pediatric primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Children 4-12 years of age presenting to MCHS Red Wing for a well child examination and vaccine administration.
* Parents or caregivers of any age presenting to well child examination with child.
* Legal guardians of all participants must provide verbal consent.
* Patients must provide verbal assent for participation.Verbal assent will be waived for children younger than 6 years.

Exclusion Criteria:

* Children with autism or other severe developmental disabilities.
* Children must be able to communicate pain before and after vaccine administration using the FPS-R.
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients

To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL


Eligibility Criteria:
Inclusion Criteria:

1. Patients with active B-CLL and with an indication for treatment
2. Age ≥ 18 years
3. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

Exclusion Criteria:

1. Any previous treatment for B-CLL or any other treatments that can be considered active against B-CLL
2. Glucocorticoid unless given in doses ≤ 10 mg /day for other indications than B-CLL (e.g. asthma)
3. Known transformation of B-CLL
4. Known CNS involvement of B-CLL
5. Past or current malignancy, except for:

   1. Cervical carcinoma Stage 1B or less
   2. Non-invasive basal cell and squamous cell skin carcinoma
   3. Malignant melanoma with a complete response of a duration of \> 10 years
   4. Other cancer diagnoses with a complete response of a duration of \> 5 years
6. Chronic or current infectious disease requiring systemic treatment
7. Clinically significant cardiac disease
8. Significant concurrent, uncontrolled medical condition
9. History of significant cerebrovascular disease
10. Known HIV positive
11. Positive serology for hepatitis B, unless due to vaccination
12. Leukapheresis, except as a safety measure before chemotherapy
13. ECOG Performance Status of 3 or 4
14. Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC regimen
15. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1
16. Current participation in any other interventional clinical study
17. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
18. Breast feeding women or women with a positive pregnancy test at Visit 1
19. Women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
Factors Associated With Chronic Respiratory Failure in Obesity

Some overweight individuals develop problems with their breathing such that they gradually breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the blood, called ventilatory failure. As a consequence, if such a person develops a chest infection, they are more likely to become seriously ill and need intensive care. In addition they are much more likely to develop severe complications during and following operations. This problem can be treated with a machine at home used overnight to help breathing. It is interesting that ventilatory failure only happens in some overweight individuals, and the investigators do not understand what factors make this complication develop. There are a number of theories: for example the distribution of the fat, additional lung disease (such as asthma), the addition of obstructive sleep apnoea, a condition when there are periods of cessation of breathing overnight (which is more common in obese individuals), weak muscles of breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other hormonal changes.

The investigators intend to measure many potential factors in a range of overweight individuals, some who have ventilatory failure, and some who do not, to try and work out which are the important factors that cause this problem. If the investigators can identify such factors, then this will help predict in advance who is at risk from chest infections and during operations; thus allowing for earlier provision of an overnight breathing machine. This should reduce complications and potentially deaths in such individuals.

To test the hypothesis that in obese patients with obesity-hypoventilation (OHS) there are specific factors related to the development of ventilatory failure, compared to obese subjects not in ventilatory failure

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI \> 30) with or without obesity hypoventilation
* (OHS) (18 - 85yrs)
* Admitted for management of their OHS
* Attending the sleep and ventilation clinic
* Being assessed for bariatric surgery
* Willing and able to give informed consent for participation in the study
* Men and women aged 18 - 85 years

Exclusion Criteria:

* Respiratory acidosis pH \<7.30
* Severe untreated hypothyroidism
* Current treatment with theophylline
* Current treatment with diuretics
* Severe restrictive or obstructive lung disease (\<30% predicted)
* Severe comorbidities such as moderate/severe COPD, left sided heart failure, and primary CNS or neuromuscular diseases
* Contraindications to MRI scanning
* Contraindications to DXA scanning
* Previous participant in research in the last 12 months
Jugular Venous Flow Healthy Volunteers

Our hypothesis is that there will be a decrease in internal jugular venous flow in the park bench position when compared to the supine position. There will also be a change in blood flow in the between right and left internal jugular veins in park bench position, particularly there will be a greater reduction of flow on the dependent side. However, the internal jugular venous flow will be the same in both the prone and supine position.

The different positions used in neurosurgery (park bench, prone) for better accessibility to the operating field can impact on the cerebral venous drainage due to the effects of internal jugular venous outflow of blood and may increase intracranial pressure. The kinking of the internal jugular vein due to excessive neck flexion and rotation in park bench or flexion in the prone position may lead to kinking or twisting of the vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and in postoperative patients may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction and increases in intracranial pressure.

Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this. Thus, we look to measure the internal jugular venous flow at different positions as there have been little studies looking at this important contributing factor.

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers who are above the age of 18
* American Society of Anesthesiologists classification (ASA) 1
* Body mass index (BMI) less than and equal to 35

Exclusion Criteria:

* ASA 2 and above
* BMI above 35
* Lack of informed consent
* Language barrier
* Medical students and anaesthesia residents going through the department as part of their rotation