cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcomes of Conservative Management in Patients with Moyamoya Disease and Their First-degree Relatives (LAMORA)

The purpose of this study is to investigate the long-term outcomes of conservative management in patients with moyamoya disease and their first-degree relatives, and provide potential pathogenesis of moyamoya disease.

Moyamoya disease (MMD) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. It is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. The specific pathogenesis of MMD is still unclear. The treatment modalities of revascularization and conservative management have been used in patients with MMD. However, the long-term outcomes of MMD with conservative management remain unknown. Also, some first-degree relatives who are carriers of genetic variants occasionally manifest with intracranial arterial stenosis. Therefore, it is significant to detect the long-term outcomes of conservative treatment in MMD patients and their first-degree relatives, and thus provide potential pathogenesis of MMD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age between 2-60 years;
2. A clinical diagnosis of moyamoya disease, including unilateral and bilateral disease.
3. Patients are medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
4. Capable of understanding the purpose and risk of the study and has signed the informed consent. If the participant is not capable of this at the time of enrollment, a legally authorized representative will provide written informed consent in accordance with all regulations.
5. Ability to comply with study follow-up.

Exclusion Criteria:

1. Concomitant other diseases, including systemic vasculitis, neurofibroma, meningitis, sickle cell disease, down's syndrome, and previous basilar radiotherapy.
2. Patients with cardiogenic embolism, including a history of atrial fibrillation, valvular disease or cardiac valve replacement.
3. Patients are allergic to the contrast agents.
4. Patients are treated with direct, indirect, or combined revascularization depending on the presentation.
5. Physical or subjective failure to cooperate with the examination or serious comorbid diseases.
6. Patients are unable or unlikely to return for follow-up visits.
7. Any other reasons that, in the opinion of the investigators, make the participant unsuitable for enrollment.
The Effects of Playful Pathways

The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. The researchers aim to screen and identify developmental delays and the effects of the 8 week program on gross motor development as well as explore parent perceptions of the program.

The aim of this study is to assess the physical, social, and emotional outcomes of an interactive group program for infants 0-6 months and their families/caregiver.


Eligibility Criteria:
All babies typically developing or any diagnosis ages 0 - 6 months; parents/caregivers of babies typically developing or any diagnosis ages 0 - 6 months participating in the intervention. Sample size will be 12 babies ages 0-6 months and their caregivers (1-2 caregivers per baby). Total population 12 infants with up to 30 caregivers.

Inclusion criteria:

1. All babies typically developing or any diagnosis ages 0 - 6 months

Inclusion criteria for parents/caregivers:

1. At least 18 years of age
2. Able to communicate in and read English
3. Parent/caregiver of baby ages 0 - 6 months who is participating in the program
4. Ability to provide transportation to/from research site(s)
Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study

The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is:

Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.

Objective: PTeye™ and FLUOBEAM® LX use autofluorescence to confirm visually suspected parathyroid tissue. Real-time intraoperative identification of parathyroid glands can be achieved by the application of both devices. The aim of the present study is to evaluate and compare the efficacy of PTeye™ and FLUOBEAM® LX in identifying parathyroid adenomas.

Methods: Patients undergoing parathyroidectomy due to a parathyroid adenoma will be enrolled prospectively in this study and will be randomly included to Group A (PTeye™) or Group B (FLUOBEAM® LX). After intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0), the efficacy of both devices to confirm the adenomas will be evaluated. Re-evaluation will take place in minutes 1, 3 and 5 during tissue dissection and before adenoma excision.

Eligibility Criteria:
Inclusion Criteria:

- Patients with Primary parathyroidism with parathyroid adenoma

Exclusion Criteria:

* Parathyroid Hyperplasia,
* Secondary hyperparathyroidism
Diabetes Prevention in Clinical Practice.

We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.


Eligibility Criteria:
Inclusion Criteria:

1. Impaired glucose tolerance
2. Age: 20-85yrs

Exclusion Criteria:

1. Type2 diabetes
2. Significant disease making life style changes unlikely to happen
3. Unable to communicate in Swedish
Molecular Hydrogen for Cognitive Function and Performance in Elderly

A variety of non-pharmacological interventions have been used in the management of Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. Although it is still unknown what triggers AD, recent studies have shown that AD is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis to be evaluated in this project is that administration of H2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from AD.


Eligibility Criteria:
Inclusion Criteria:

* Age over 65
* No psychiatric comorbidities

Exclusion Criteria:

* Use of dietary supplements 4 weeks before study commence
Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children

The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

An unexpected increase of shock with fever in children suspected to be infect by the COVID-19 is observed. These children present with similar symptoms and seem to have similar clinical time course.

This unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.

The study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.

The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years
* Admitted to PICU from April 2020
* Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection

Exclusion Criteria:

* Age ≥ 18 years
* Other etiologies of acute myocarditis than the COVID-19
* Opposition expressed by the holders of parental authority
STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies

Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer.

Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of high-grade cancers compared to the currently used systematic biopsies, but existing evidence are contradictory and not free from methodological flaws.

The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers by introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The primary endpoints are the number of performed biopsies and the number of detected high-grade prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences of implementing MRI based prostate cancer diagnostics and to improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm.

The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately. Based on power calculations, approximately 500 planned for prostate biopsies will be included in the first phase. Men who have previously been diagnosed with prostate cancer may not take part in the study. The study period of Phase 1 is March 2016 to January 2017. The second phase will start in autumn 2016 and end by December 2017.


Eligibility Criteria:
Inclusion Criteria:

* Men age 45-75 years referred to any of the participating urological centers for prostate biopsies

Exclusion Criteria:

* A prior diagnosis of prostate cancer (ICD-9 C61)
* Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
* Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
Engaging Elderly People Living in Institutions in Eating Situations

Several recent studies have revealed a significant under-consumption of food in hospitals and nursing homes. For instance, at the Dijon University Hospital, 8 out of 10 patients consume less than 80% of the meals served. This has two consequences: an increase in the risk of malnutrition (some patients leave the hospital in such a poor nutritional state that they must be re-hospitalized within six months) and significant food waste. At the heart of this problem, the taste of the food is the subject of frequent and recurrent complaints from users. Although the food industry widely uses sensory methods to adapt its products to the taste of consumers, these methods are rarely used by the organizations that provide meals to care institutions.

The objective is to establish "taste commissions" in the daily practice in institutions for the elderly (hospital, nursing home), in order to improve the organoleptic quality of the meals served according to the expectations and preferences of the users. The principle of this system is to allow the users to taste the dishes produced by the kitchen of the establishment and to transmit these evaluations to the cooks so that they can rework the recipes according to the users' feedback.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients:

* Person hospitalized in one of the following departments: the endocrinology-diabetology department, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as the rehabilitation department, which are departments with an average length of stay sufficient to perform the study
* Person aged ≥ 50 years (this choice was made because more than 60% of the hospitalized population is currently over 50 years old)
* Person having given their oral agreement
* Person with an oral diet and eating without assistance
* Person with a normal texture diet
* For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE \> 21).

Residents in nursing home (EHPAD):

* Person residing in EHPAD
* Person aged ≥ 65 years
* Person having given oral consent
* Person who is orally fed and self-feeding
* Person with a normal texture diet
* For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE \> 21).

Facility staff for SWOT interviews:

* Person who has worked at the facility where the taste commissions were implemented at least 3 months previously.
* Person who gave oral consent
* Person between the ages of 18 and 60

Exclusion Criteria:

* Person at the end of life
* Person with an eating disorder
* Person with a significant chronic psychiatric disorder (psychosis, manic-depression).
* Person requiring enteral or parenteral nutrition.
* Person in a period of exclusion from a previous study
The Effect of Platelet Rich Plasma on Non-scarring Alopecia

The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or injections of normal saline (placebo). Patients in the treatment group (Group A) will have a small amount of their own blood drawn and have their PRP injected into their scalp four times. The injections will be given at weeks zero, four, eight, and twenty four. The placebo group (Group B) will be given the same schedule but will receive sham injections only and will not have any blood drawn. Both groups will have clinical data collected at all visits, including a screening visit before enrollment and a final assessment visit at week 40, for a total of 6 study visits per patient. Data collection will include representative photographs of the scalp and measurements of hair thickness. The results from the two groups will then be compared.

In summary, all study participants will have a screening visit before enrollment, four study visits for sub-dermal scalp injections, and one final assessment visit at week 40.


Eligibility Criteria:
Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form
2. Must be female between the ages of 18 and 65 years at the time of consent
3. Must be able to adhere to the study visit schedule and other protocol requirements
4. Documented platelet count above 150,000 platelets per microliter within 6 months prior to enrollment

Exclusion Criteria:

1. Previous or current use in the last 1 year of finasteride, minoxidil topical or oral, or spironolactone
2. A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia )
3. No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative urine pregnancy test in any pre-menopausal female in past 12 months.
4. Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
5. Scalp infection
6. Severe active blood infection
7. Cuts or abrasions on the scalp
8. History of surgical hair restoration
9. Current or recent malignancy
10. History of systemic chemotherapy or radiation
11. History of thyroid dysfunction
12. History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or systemic lupus erythematosus)
13. Tendency to develop keloids
14. Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days
15. Platelet dysfunction syndrome
16. Thrombocytopenia less than 150,000
17. Diagnosis of hypofibrinogenemia
18. Anticipated pregnancy or trying to become pregnant in the next 2 years
Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)

Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.

Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation, which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that activates the acute phase CRP response.

Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Medically optimized COPD patients
* Age 40-79 years.
* serum CRP levels \>3mg/l

Exclusion Criteria:

* Current smoker
* COPD exacerbation in the last 2 months.
* Active hepatic or severe renal dysfunction.
* connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (\>10,000 white blood cells) or thrombocytosis (\>450,000 platelets).
* Recent h/o myocardial infarction, angina in the last 6 months.
* Pregnancy.
Gender Related Coping and Survivorship for Genitourinary Cancers

This research is being done to learn more about coping and survivorship of women with bladder cancer, specifically regarding psychosocial distress and sexual dysfunction. This study is a non-therapeutic study and will randomize participants to a standard of care group and education group. Patients in both groups will be asked to complete surveys regarding their mood and sexual function. Patients in the intervention group will be asked to complete attendance diaries regarding educational and support services utilized. Participants' clinical data will also be collected.

The Gender Related Coping and Survivorship Study for Genitourinary Cancers is focused on providing patients with additional education to promote sexual function in female bladder cancer patients with the aim to help decrease demoralization and sexual dysfunction. Patients receiving a cystectomy and patients not receiving a cystectomy will be randomized separately into an additional education or standard of care group. The additional education consists of asking patients to attend the Women and Bladder Cancer Educational Series, Women's Bladder Cancer Support Group meetings, referrals to other support services, receiving supplemental handouts and treating physician led counseling incorporated into standard of care visits. All participants will be asked to complete the Demoralization Scale-II and Female Sexual Function Index at baseline, one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment. Patients randomized to the additional education group will also be asked to complete an attendance diary one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Females with bladder cancer
* Willing to answer surveys regarding their psychosocial health and sexual health

Exclusion Criteria:

* Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)
* Patients with cognitive impairments
* Women who are pregnant
Functional Effects of Botox on the Brain Using MRS and fMRI

The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in a growing number of indications including disorders involving skeletal muscle (e.g., strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g., bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014). Recently, several studies have suggested that peripheral BOTOX injections in the region of the glabellar lines (muscles around the eyes) may be effective in treating major depression and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX injections on the brain is not well understood. Therefore, the Investigators propose to further explore the functional effects of BOTOX injections on brain in healthy controls. The approach will involve the measurement of brain metabolites in the brainstem using MRS as well as an investigation of the functioning and connectivity between regions of the brain using resting state MRI and high resolution fMRI.

Participants will receive one MRI scan session prior to a standardized, clinical dose of BOTOX injected into the forehead per FDA-approved procedures. Participants will then undergo a second MRI scan session 2-3 weeks later, after the BOTOX has taken maximal effect. Examining fMRI of the brainstem and the functional connectivity of the brainstem and connections to cortex, may provide additional insight into the effects of BOTOX on neurologic and psychiatric disorders.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Ages 30-40 years of age
* Right-handed
* Normal or corrected-to-normal vision
* No history of psychiatric, neurological, or medical co-morbidities that might interfere with normal brain functioning
* Fluent in English
* Moderate to severe glabellar lines

Exclusion Criteria:

* Pregnancy
* Ferrous metal, a pacemaker, or other battery-operated device implanted in the body
* Claustrophobia
* Known hypersensitivity to Botulinum Toxin
* Infection on the forehead or between the eyes
* Urinary tract infection