cyrilzakka/clinical-trials huggingface dataset:
Westlake Nutrition and Brain Health Study

Westlake Nutrition and Brain Study (WEBRAIN) is a sub-study of the Guangzhou Nutrition and Health Study, a prospective cohort among participants living in Guangzhou city. The aim of the WEBRAIN is to investigate the relationship between diet, gut microbiome and brain health in the elderly individuals via deep phenotyping the participants including continuous blood glucose monitoring for standard test meal, objective physical activity measurement and brain magnetic resonance imaging.

The gut-brain axis has been considered a possible cause of neurodegenerative diseases via various mechanisms, and diet/nutrition has been linked to both gut and brain health. However, majority of related evidence derived from animal models or human study of small scale.

In the WEBRAIN, we aim to investigate the relationship between diet, gut microbiome and brain structure and function in a large human cohort study via deep phenotyping the participants: 1) objective measurement of physical activity using accelerometers over 2 weeks; 2) continuous blood glucose monitoring over 2 weeks, with two standard test meal during the 2 weeks, and traditional diet assessment with FFQ and 24h recalls; 3) measurement of cognitive function and brain images with the Addenbrooke's Cognitive Examination-Revised (ACE-R) and brain MRI; and 4) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques.

Eligibility Criteria:
Inclusion Criteria:

Participants within the Guangzhou Nutrition and Health Study, without Alzheimer's disease, lived in Guangzhou, China, and aged 45 years or older;

Exclusion Criteria:

Participants with cancer and other serious medical disorders.
Hypertension in Black Americans: A Life Course Approach

To investigate the relationship between life-stress factors associated with socioeconomic conditions and hypertension.

BACKGROUND:

Increasingly, researchers are recognizing that risk for cardiovascular disease (CVD) in adulthood is rooted in the social and material life conditions of childhood, and that these childhood conditions may predict risk for CVD above and beyond traditional adulthood indicators of socioeconomic status (SES) such as education, occupation or income. Nowhere is this life course perspective on CVD risk more important than in the case of African Americans, especially the generation that "came of age" in the U.S. South in the late 1950s and 1960s, the peak years of the modern Civil Rights Movement. While some African American members of this age cohort were able to take advantage of the new opportunities for economic advancement, some others were not, resulting thereafter in different life course trajectories of exposure to social and economic hardship. The relationship between variations in these social and economic life course trajectories, and CVD risk (specifically hypertension) in adulthood, has not been investigated in African Americans.

DESIGN NARRATIVE:

The study uses the Pitt County, (NC) cohort, a community sample of African Americans (N=1784, 66 percent female, 80 percent response rate) who were between 25-50 years of age at baseline in 1988. Normotensives in the baseline sample were re-examined in 1993 (N=1195, 66 percent female, 85 percent response rate). In addition to measuring blood pressure, extensive data on psychosocial, behavioral, and anthropometric characteristics were obtained at both times. The study re-examines the original cohort in 2001; the anticipated sample size is 1142 individuals (717 women and 425 men). Starting from age 20, respondents' reported exposure to three domains of socioenvironmental stressors will be assessed: (1) adverse socioeconomic conditions; (2) low levels of social integration; and (3) racial discrimination. Taken individually, and then collectively, the greater the cumulative life course exposure to these stressors, the greater the risk for adult hypertension is expected to be. The primary analyses will focus on the relationship between pre-1988 exposures and 1988 blood pressure status (retrospective analyses), and the relationship between pre-1988 exposures and changes in blood pressure status between 1988 and 2001(prospective analyses).

Eligibility Criteria:
No eligibility criteria
Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura

Thrombocytopenia refers to a reduction in platelet count to (\<150 × 109/L). Immune thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated thrombocytopenia and the exclusion of other causes of thrombocytopenia

Helicobacter pylori was recently demonstrated as an etiological factor in immune thrombocytopenic purpura in some prospective studies, with reports of platelet numbers increasing in these patients after Helicobacter pylori eradication treatment.However, other studies have shown a negative result after eradication treatment of Helicobacter pylori infection in patients with chronic immune thrombocytopenic purpura, leading to controversy.

Eligibility Criteria:
Inclusion Criteria:

1. chronic immune thrombocytopenic purpura patients who still have thrombocytopenia \> 12 months
2. age \<18 years .
3. diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count \<100×103/μL .
4. Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura .

exclusion criteria:

1. Patients with acute immune thrombocytopenic purpura . .
2. age \>18 years.
3. thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis.
4. previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin

Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic blisters. Neonatal period and infancy are critical since this autonomic dominant affection usually improves with age. Cyclins seem to be efficient in some cases of EBS but are prohibited in children younger than 8 years old. Erythromycin can be a good alternative in this population due to its antibacterial and anti-inflammatory potential.

The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old after 3 months of treatment.

Primary end point is the number of patients with decrease of blisters' number of at least 20% after 3 months of treatment by oral erythromycin.

It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3 months. Follow up for each patient is 5 months. The duration of the study is 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Severe Dowling Meara EBS patients (2 or more new blisters a day)
* signature of informed consent
* Patient of 2 sexes
* Age from 6 months to 8 years. From this age we consider that the patient will less need this treatment or can take cyclines.
* Systematic Obtaining of the consent lit(enlightened) by the relatives(parents) of the child, after information about the objectives and the constraints of the study.
* Agreement of the minor
* Patient member to the Social Security

Exclusion Criteria:

* Patient allergic to the erythromycin
* Patient presenting an intolerance to the fructose, a syndrome of malabsorption some glucose and some galactose or a deficit sucrase-isomaltase
* Renal and\\or hepatic Insufficiency
* Patient taking a medicine against indicated or misadvised in association with the erythromycin
Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults

This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary intakes, appetite, and metabolic profile in overweight and obese young and middle-aged adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30-39.9

Exclusion Criteria:

* Pregnant or lactating
* On medications that are interfered with by consuming grapefruit juice
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)

To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.

Nothing to describe.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy
2. Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
3. Aged 15-69 years
4. No prior chemotherapy or radiotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
6. Preserved organ (bone marrow, liver, kidney, heart and lung) functions
7. All patients were required to provide written informed consent

Exclusion Criteria:

1. Diabetes mellitus necessitating treatment with insulin
2. Active systemic infection
3. Cardiac disorders expected to become worse as a result of the DOX-containing regimen
4. Acute hepatitis, chronic hepatitis or liver cirrhosis
5. Positive for HBs Ag or anti-HCV Ab
6. Active concurrent malignancy
7. Other serious medical or psychiatric conditions
8. Pregnancy or breast feeding
9. Central nervous system involvement by ATL cells
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.


Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria of hepatocellular carcinoma
* Ages Eligible for Study: ≤75 years old;
* The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
* After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
* Surgery cannot be allowed;
* Informed consent from the patient.

Exclusion Criteria:

* Serious problem of heart, lung, or kidney with severe dysfunction;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
* Participating in other drug trials;
* Who are allergic to the study drug.
Impact of a Pain Neuroscience Education Program on Primary Students with and Without Intellectual Disabilities

This observational study evaluates the impact of a Pain Neuroscience Education (PNE) program on primary school students in Extremadura, Spain. The study examines satisfaction levels and knowledge acquisition regarding pain neuroscience among students with and without intellectual disabilities. Conducted across both rural and urban educational centers, as well as special and regular education schools, this study aims to identify the effectiveness of PNE in enhancing pain-related knowledge and addressing Sustainable Development Goals (SDGs) awareness. Additionally, the program includes interactive educational activities tailored for accessibility, using resources such as easy-to-read questionnaires and hands-on models, to support inclusive health education. Data collection involves pre- and post-intervention questionnaires to assess satisfaction and knowledge gains, with statistical analysis exploring differences between demographic and school-type groups.


Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in the fifth or sixth grade of primary education in schools within the Autonomous Community of Extremadura.
* Students who regularly attend academic activities and complete the educational intervention.

Exclusion Criteria:

* Students who do not attend school regularly or who are not expected to complete the intervention.
* Students with severe cognitive or behavioral impairments that may interfere with participation in the educational activities.
Allopurinol to Prevent Cirrhosis Related Morbidities

The study aims to compare the potential benefit of allopurinol in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival. Furthermore, the study aims to evaluate their impact on parents' related quality of life

Cirrhosis is the late stage of liver damage and possess two phases: a compensated phase with favorable prognosis and a decompensated phase with high mortality rate.The shift from compensated to decompensated cirrhosis is characterized by the onset of complications, including ascites, hepatic encephalopathy (HE), variceal bleeding, and spontaneous bacterial peritonitis (SBP) which are associated with substantial morbidity and negative Impact on quality of life (QOL).

The gut microbiota plays an important role in cirrhosis and development of cirrhosis-related complications.

Indeed, translocation of endotoxins is increased in patients with cirrhosis and patients with more severe cirrhosis (i.e. Patients with decompensated cirrhosis, hospitalized patients) had significantly greater serum endotoxin concentrations that mediate complications of cirrhosis.

Intestinal permeability plays a role in the development of bacterial translocation and may be involved in the development of complications of cirrhosis. This 'leaky gut' phenomenon increases with the degree of liver failure and is particularly prominent in patients with cirrhosis who have experienced severe septic complications and has been implicated in the hepatic production of endotoxin-associated proinflammatory cytokines.

Intestinal mucosa alterations at the subcellular level have been reported in experimental cirrhosis, in relation to an increased oxidative stress due to overactivity in the enzyme xanthine oxidase.

Allopurinol, a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation in portal hypertensive animals, suggesting that the damaging effects of oxygen-derived free radicals and peroxidation on mucosal cells may be counteracted by a free radical scavenger.

In 2007, a pilot study demonstrated that allopurinol in patients with cirrhosis is associated with a significant reduction in oxidative stress but no effect on intestinal permeability and inflammatory markers. The study duration was only 10 days and therefore another study with a long period of time is essential.

Eligibility Criteria:
Inclusion Criteria:

* ge 18 to 75 years old Both sex Adults with cirrhosis in a stable conditions

Exclusion Criteria:

* Active SBP Renal insufficiency (serum creatinine \> 2.0 mg/dl) Active GIT hemorrhage
Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint

The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.

The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.


Eligibility Criteria:
Inclusion Criteria:

Arthroplasty group:

* DIP silicone arthroplasty at least one year ago
* Informed consent as documented by signature

Arthrodesis group:

* Matched patients with an DIP arthrodesis
* Informed consent as documented by signature

Exclusion Criteria:

Arthroplasty group:

* Silicone arthroplasty at the thumb IP joint
* Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Arthrodesis group:

* Arthroplasty at another DIP joint
* Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires
Prostate Tissue BioBank

Prostate cancer is also the most common cancer in men with inherited pathogenic variants in BRCA1 and BRCA2. Beyond BRCA1/2, other genes are known to increase the risk of prostate cancer, including ATM, TP53 and HOXB13. We have shown that 5% of men diagnosed with prostate cancer localized to their prostate gland and up to 10-15% of patients with metastatic prostate cancer gland are carriers of an inherited gene mutation.

The Prostate Tissue BioBank is a prospective study which aims to create a biorepository of prostate tissue samples from prostate biopsies and prostatectomies and matched germline DNA from pathogenic mutation carriers in addition to age-matched control samples. Our primary goal is to investigate prostate cancer development and treatment response in carriers of germline DNA repair mutations, as compared to non-carrier controls.


Eligibility Criteria:
Inclusion Criteria:

Carriers (Group 1):

1. Confirmed pathogenic or likely pathogenic variant in a known prostate cancer risk gene.
2. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Controls (Group 2):

1. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Exclusion Criteria:

* N/A
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis

The aim of the study is to evaluate the effects of a 12-week internet-based exercise and physical activity promotion intervention on physical activity. Furthermore, effects on symptoms of Multiple Sclerosis, Physical Activity-related Health Competence (PAHCO), self-concordance and basic needs satisfaction as well as usability and acceptability of the intervention will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed Multiple Sclerosis (McDonald criteria)
* Expanded Disability Status Scale between 0 - 6.5
* neurologically stable (no exacerbation within 30 days prior to enrollment)
* internet access (WiFi)
* basic knowledge on handling personal computer and the internet
* owning a smartphone with the operating system Android or IOS and with access to Google Play Store or Apple App score
* basic computer and internet skills (e. g. using web browser and webcams)
* ability to operate a smartphone (especially to install mobile applications)
* ability to read, write and comprehend as well as communicate electronically

Exclusion Criteria:

* regularly physically active (more than 30 minutes twice a week with at least moderate intensity; includes aerobic training, resistance training and other sports e.g. Tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.)
* clinically relevant cardiovascular diseases
* cortisone therapy in the last 30 days
* cognitive impairment that hampers study implementation
* severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
* severe internal, orthopaedic and metabolic diseases that restrict mobility
Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)

To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.

This is a single-center phase Ib study to investigate the safety and tolerability of the combination of PEMF with anthracycline-based chemotherapy. Subjects will be enrolled on a 3+3 dose escalation design from dose level 1 with a target to reach dose level 4, where PEMF can be administered prior to each cycle of anthracycline-based chemotherapy. In the first 2 dose levels, PEMFs will first be administered to subjects who are planned for upfront surgical resection to ensure that PEMFs is safe and tolerable for up to 0.5-hour. Once the duration of each PEMF treatment is established, PEMFs will then be added to anthracycline-based chemotherapy to investigate the safety and tolerability of the combination treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)
2. ECOG 0-1.
3. Non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy
4. Adequate organ function including the following:

   1. Bone marrow:

      1. Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 10\^9/L
      2. Platelets \>= 100 x 10\^9/L
      3. Hemoglobin \>= 8 x 10\^9/L
   2. Hepatic:

      1. Bilirubin \<= 1.5 x upper limit of normal (ULN),
      2. ALT or AST \<= 2.5x ULN, (or \<=5 X with liver metastases)
   3. Renal:

      1. Creatinine \<= 1.5x ULN
5. Signed informed consent from subject or legal representative.
6. Able to comply with study-related procedures.

Exclusion Criteria:

1. Pregnancy.
2. Breast feeding.
3. Presence of fungating breast tumor or open wound in breast planned for PEMF.
4. Active bleeding disorder or bleeding site.
5. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
6. Major surgery within 28 days prior to study administration.
7. Non-healing wound.
8. Active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
9. History of significant neurological or mental disorder, including seizures or dementia.
10. Serious concomitant disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.
Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in Major Depression

Major depression is characterized by vestibular anomalies. The investigators hypothesized that vestibular stimulation will improve depression symptoms in major depression patients.


Eligibility Criteria:
Inclusion Criteria:

* major depression patients,
* actual Hamilton score \> 14

Exclusion Criteria:

* pregnant,
* neurological disorders,
* epilepsy,
* bipolar disorder,
* schizophrenia,
* anorexia,
* bulimia.