cyrilzakka/clinical-trials huggingface dataset:
Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women

This study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that these tumors increase in size in the evening, but this result could stem from the fact that previous study participants were tested after eating lunch. The purpose of the study is to help researchers understand the factors that produce changes in size of lymphangioleiomyomas, as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas and avoid confusing these tumors with other malignant tumors.

Volunteers must be women who are at least 18 years of age and who have been diagnosed with lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a physical examination and medical history.

During the study, participants will be admitted to a National Institutes of Health clinical center for three days to undergo a number of tests. Tests will include routine blood and urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic ultrasounds....

Lymphangioleiomyomatosis (LAM) is a rare disease of women that is characterized by a proliferation of abnormal smooth muscle-like cells (LAM cells) in the lungs, which leads to cystic destruction of the lung parenchyma, in the axial lymphatics, resulting in lymphangioleiomyomas, and in abdominal angiomyolipomas, primarily in the kidneys. Lymphangioleiomyomas may cause abdominal distension and compress abdominal organs, producing obstipation, bladder obstruction and neurological deficits. Leakage of chyle may be responsible for ascites and pleural effusions. The lymphangioleiomyomas may change in size during the day. This variation in tumor size may be due to increased chyle formation or alterations in lymphatic flow. These studies however, were not performed with research subjects who were fasting. Our hypothesis is that the ingestion of food increases chyle formation and lymphatic flow, which in turn increases the size of the lymphangioleiomyomas. The aim of this study is to test this hypothesis. We propose to conduct a study in 30 LAM patients who have lymphangioleiomyomas to determine whether the ingestion of food, by increasing chyle formation and lymphatic flow, increases the size of the lymphangioleiomyomas.

Eligibility Criteria:
* INCLUSION CRITERIA:

Individuals who are 18 years of age or older with any of the following:

1. Lymphangioleiomyomatosis
2. Abdominal or pelvic lymphangioleiomyomas equal to or greater than one centimeter in diameter in the non-fasting state.

EXCLUSION CRITERIA:

Individuals with any of the following:

1. Lung transplantation
2. Kidney transplantation
3. Lymphangioleiomyomas smaller than one centimeter in diameter in the non-fasting state.
4. Pregnancy or lactation.
5. Type 1 diabetes.
6. Inability to give informed consent.
7. Currently taking rapamycin.
A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey

The aim of Wakey! is to increase access to wellbeing support to lower socio-economic groups who have traditionally been excluded from the design and evaluation of digital mental health interventions. This feasibility study is designed to explore engagement, initial efficacy and experience of using Wakey! in the underserved populations in the United Kingdom. This will be used to further adapt and refine the intervention, so it is appealing and effective in the target populations.

Mental health conditions are a considerable burden for patients and health services and have been shown to have social patterning in severity and incidence. Children and adults living in the lowest 20% income bracket are two to three times more likely to develop a mental health condition than those people living in the top 20% bracket. Unemployment, working in jobs with low pay and insecure work have been found to be detrimental to mental health. Mental health services are struggling to cope with demands on services, and unequal access to support is further exacerbating health inequalities.

Digital interventions have been proposed as a solution to address the high demand for mental health support in the context of the crisis in healthcare services. These interventions provide the potential to reduce health disparities, by providing personalised low-cost infinitely reusable resource that can increase access to health interventions. However, these interventions may increase inequity, where access and usability for disadvantaged groups remain barriers. To ensure health inequalities are not further exacerbated, there is a need to develop digital interventions that are appealing and accessible those from lower socioeconomic groups. These are social groups that currently look to entertainment to regulate difficult emotions and for education.

An initial pilot of the 9-minute show was trialled in the United Kingdom with a lower socio-economic group and was well received. The app was advertised through the companies that partner with Lost In TV Audience Services, who has a database of 450,000 people. In the initial pilot 43,000 people opened the email about the app. The live morning breakfast show that ran for two weeks was used by 450 participants. The findings were that 50% watched all 10 shows, 65% said that would download the app "today", 70% said it was easier to get out of bed, 53% saw an increase in life satisfaction, and 67% reported an increase in self-efficacy.

The primary objectives of the feasibility study are:

* To assess how many people download the app in the target population
* To assess participant's engagement with the app over the 12-week trial period

The secondary objectives are:

* To explore efficacy data on Office for National Statistics well-being outcomes, sleep and self-efficacy outcomes and to see if there are any changes throughout the trial
* To explore, quantitatively and qualitatively, participants' experiences of using Wakey!

Eligibility Criteria:
Inclusion Criteria:

* App users who are at least 18 years old.
Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients

This study is a retrospective comparative evaluation of six main periodontal pathogens and total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes mellitus by polymerase chain reaction analysis.

The aim of this study was to compare prevalence and bacterial load of six main periodontal pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus. Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also investigated.

The recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test.

For each subject, the following data have been collected: age, gender, smoking habits, type of metabolic control of diabetes, duration of diabetes, number of missing teeth.

For each subject, four periodontal sites were studied. Probing pocket depth, sites with bleeding on probing, sites with suppuration and microbiological data were evaluated.

An individual matching on the basis of severity and extension of periodontitis was performed by pairing a diabetic patient with another non-diabetic one with the same degree of severity and extension of the periodontal disease.

Microbiological data of subgingival biofilm were analysed and compared for the examined pathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, Fusobacterium nucleatum, Tannerella forsythia.

Differences in genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic periodontitis
* diagnosis of type 2 diabetes mellitus (only in the test group)
* the presence of at least 12 teeth (except for the third molar)
* belonging to caucasian ethnic group
* age greater than 18 years.

Exclusion Criteria:

* pregnant or lactating
* history of systemic antibiotics within 3 months prior to the microbiological testing or anti-inflammatory therapy in the month before the visit
* if they were suffering from any other systemic disease except diabetes mellitus (arthritis, ulcerative colitis, Crohn's disease, osteoporosis or osteopenia, HIV infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or pathologies that could potentially interfere with the periodontitis and/or with diabetes)
* mental disorders
* if they had received periodontal treatment in the 6 months before the microbiological test.
Safety and Efficacy Study in Patients With Retinitis Pigmentosa Due to Mutations in PDE6B Gene

The study is a Phase I/II, monocentric, open-label, dose-ranging safety and efficacy gene therapy intervention by subretinal administration of AAV2/5-hPDE6B.

At least twelve patients 18 years of age or older, within four consecutive cohorts of patients, will be recruited.

Then at least four patients 13 years of age or older, within a fifth cohort, will be recruited.

Retinitis pigmentosa (RP) is a disease where part of the eye (the retina) is degenerating over time. Patients initially present with night blindness, and later in life experience loss of central vision which leads to blindness. RP is a highly variable disorder with some patients developing symptomatic visual loss in childhood whereas others remain asymptomatic until mid-adulthood. There are no treatments available.

This study focuses on the form of RP caused by mutations (modifications) in the genetic information necessary to make the protein called rod cGMP phosphodiesterase 6 β subunit (or PDE6β). Clinical diagnosis is made by function tests of the eye and confirmed using a specific method called molecular testing to verify that the PDE6B gene is not correct.

This study uses a gene therapy vector inspired from an adeno-associated virus (AAV) called AAV2/5-hPDE6B. This vector intends to supply to the target cells the PDE6B therapeutic gene that is not functioning properly in the cell. The AAV parts of the gene therapy vector work as a vehicle to deliver the normal human PDE6B gene into the cells of the retina.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical and molecular diagnosis of retinitis pigmentosa caused by defect in PDE6B gene without other syndromic manifestations
* Aged above 13 years
* Ability to give informed consent

Key Exclusion Criteria:

* Previous ocular surgery or thermal laser within 6 months before the surgery
* Lens opacities or obscured ocular media upon recruitment such reliable evaluation or grading of the posterior segment cannot be performed
* Known serious allergies to the fluorescein dye used in angiography, to the mydriatic, steroidal and non-steroidal eye drops
* Participation in another clinical trial with an investigational agent
* Enrolled or being enrolled in another gene therapy clinical trial
* Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents
* Chronic medical conditions, cancer
* Abnormal laboratory values
* On immunosuppressive therapy
Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy

The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications
LIPEDEMA AWARENESS IN FIBROMYALGIA

Lipedema is a chronic debilitating condition that impacts the subcutaneous adipose tissue of the extremities. It is a chronic condition but should not be regarded as always progressing.The clinical course varies individually and is unpredictable. It may considerably diminish the patient's quality of life. Fibromyalgia, similar to lipedema, is a debilitating chronic pain disease of unclear origin that primarily affects women. It is a complex syndrome marked by widespread pain and tenderness. Fibromyalgia and lipedema are both marked by pain related to soft tissue. Both disorders are not amenable to curative treatment, resulting in a significant burden on individual and public health. No definitive indicators, including abnormal laboratory or imaging results, can be discerned to differentiate one disorder from another.

With this perspective, the aim of our study was to evaluate the presence of lipedema and lipedema-related factors in fibromyalgia patients.


Eligibility Criteria:
Inclusion Criteria:

* female patients
* over the age of 18
* who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria

Exclusion Criteria:

* renal or cardiac insufficiency,
* the use of any drug that could influence body fluid and electrolyte balance,
* the presence of a major somatic disease.
Immediate Mobilization After Cardiac Catheterisation

The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.

The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime.

There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI.

Eligibility Criteria:
Inclusion Criteria:

* CAG or PCI performed via the femoral artery
* No hematoma in the groin (\> 5 cm in diameter)
* Heparin reversed with protamine after PCI

Exclusion Criteria:

* Oozing, bleeding or hematoma
* Treatment with Integrilin, ReoPro, or Marevan
* Heparin can not be reversed
* The patient does not want to participate
* Systolic blood pressure \> 180 mm Hg after the procedure
* BMI\> 35 (can be modified if the groin can be assessed in an upright position)
* Demented, unconscious patients who do not understand the information for participants.
Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas

The investigators' long-term goal is to improve the survival of patients with pancreatic cancer by enhancing the efficacy of gemcitabine-radiation by adding the Wee1 inhibitor MK-1775.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically confirmed adenocarcinoma of the pancreas.
* Patients will have unresectable disease, defined radiographically as \>180 degrees involvement of the superior mesenteric artery or celiac trunk or SMV/portal vein impingement that cannot be surgically reconstructed, in the absence of distant metastasis..
* Patients must have a Zubrod performance status (measure of general well being that ranges from 0 to 5 where 0 represents perfect health) of \< 2.
* Patients must have adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent)) and AST \< 5 times the upper limit of normal.
* Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial. Patients must not be breastfeeding.
* Patients must be aware of the investigational nature of the therapy and provide written informed consent.
* Patients must be at least 18 years old.

Exclusion Criteria:

* Other serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
* A history of previous chemotherapy for pancreatic cancer or abdominal radiation therapy.
* The use of any investigational agent in the month before enrollment into the study.
* Inability to discontinue a prescription or non-prescription drugs or other products known to be metabolized by CYP3A4, or to inhibit or induce CYP3A4 prior to Day 1 of dosing and to withhold throughout the study until 2 weeks after the last dose of study medication. Medications of particular concern are the following inhibitors of CYP3A4: azole antifungals (ketoconazole itraconazole, fluconazole and voriconazole), macrolide antibiotics (erythromycin, clarithromycin), cimetidine, aprepitant, HIV protease inhibitors, nefazodone and the following inducers of CYP3A4: phenytoin, barbiturates and rifampicin. Substrates of CYP3A4 include statins (lovastatin, simvastatin), midazolam, terfenadine, astemizole, and cisapride.
A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts

This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.

The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use for the iTotal® CR
2. Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
3. Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
4. \> 18 years of age

Exclusion Criteria:

1. Simultaneous bilateral procedure required
2. BMI \> 40
3. Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
4. Poorly controlled diabetes
5. Neuromuscular conditions which prevent patient from participating in study activities
6. Active local or systemic infection
7. Immunocompromised
8. Fibromyalgia or other general body pain related condition
9. Rheumatoid arthritis or other forms of inflammatory joint disease
10. Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
11. Diagnosed with or receiving treatment for Osteoporosis
12. Other physical disability affecting the hips, spine, or contralateral knee
13. Severe instability due to advanced loss of osteochondral structure
14. Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
15. Compromised PCL or collateral ligament
16. Severe fixed valgus or varus deformity of \>15º
17. Extensor lag \> 15º
18. Fixed flexion contracture ≥ 15º
19. Unwilling or unable to comply with study requirements
20. Participation in another clinical study which would confound results
21. Allergy to any of the implant materials
Maternal Grandmothers in the Born in Guangzhou Cohort Study

The MGBIG is a study exploring cross-generational effects in 5000 women and their children and grandchildren located in Guangzhou, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology and on explaining the cause of the disease from the perspective of "grandmother-mother-child" heredity. Data are collected regarding environmental exposures, lifestyle, and social support on grandmother from birth to old age. Biological samples including blood and tissue samples are collected.

It was previously believed that heredity strictly follows Mendel's laws, but recent studies have found that through placental material exchange, mammals may transfer maternal immune-related factors vertically, thus promoting the protection of "non-heredited maternal antigenic traits". Thus, the transmission of reproductive information across generations is realized. Since the unusual genetic pattern of the X chromosome, grandmother's influence may be gender specific. Since grandchildren were usually took care by grandparents in China, it could be achievable to attach and recruit maternal grandmother together with mother and children. Cohort including three generations of women is rare in Asia at present. In the MGBIG, extensive information including demographic characteristics, lifestyle, history of diseases, mental health, and behaviors is collected from the participants. Longitudinal follow up and surveillance of common chronic diseases are also to be conducted. The MGBIG intends to recruit maternal grandmothers to study the effects of maternal genetic and environmental exposure on the health of their children and grandchildren.

Eligibility Criteria:
Inclusion Criteria:

1. Maternal Grandmother' grandchildren delivered in Guangzhou Women and Children's Medical Center
2. Baseline information of maternal grandmother's daughter during pregnancy available

Exclusion Criteria:

1. Significant cardiovascular abnormalities
2. Intelligent obstacle, intellectual disabilities or gawkish condition