cyrilzakka/clinical-trials huggingface dataset:
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

The hypothesis of this study is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels.

All subjects will be randomized to once daily 5-ASA medications at two different times of the day: between 06:00 - 10:00 h or 18:00 - 22:00 h. Three disease assessments will performed at: 1) enrollment just before randomization; 2) month 3, at the completion of first arm (Condition 1), and 3) month 6, after completion of the second arm (Condition 2). During these study time points, participants will be asked to complete questionnaires, track their 5-ASA medication usage, provide a stool sample, blood draw, urine test, collect saliva, wear a watch to measure sleep patterns, and complete a flexible sigmoidoscopy.


Eligibility Criteria:
Inclusion Criteria: Study will include individuals that are;

1. M/F, 18-65 years of age
2. Ulcerative Colitis with Inactive Disease (Mayo Score ≤ 2; partial Mayo Score ≤ 1 with endoscopic score 0-1)
3. Subclinical inflammation stool calprotectin \> 50 or CRP \> mg/L above the upper limit of normal or PROMIS Fatigue Score ≥ 50)
4. Stable medications with no disease flares for the \> 3 months,

Exclusion Criteria: Study will not include individuals that are;

1. Active UC at enrollment (Mayo \> 2 and/or sigmoidoscopy score of 2 or 3)
2. Regular use of suppositories or enemas within the last 3 months ORA: 20052807-IRB01 Date IRB Approved: 11/6/2023 Amendment Date: 4/7/2024 Protocol Version Date: 4/4/2024 7
3. Use of biologics or immunomodulatory medications ( i.e. infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
4. Prior ostomy or subtotal colectomy
5. Recent prednisone or antibiotic use in last 12 weeks
6. Major Depression identified as Beck Depression Inventory (score ≥21)
7. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale)
8. Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)
9. Clinically significant diabetes (Hgb-A1c\>7)
10. Regular use of medications that affect intestinal permeability, intestinal motility and/or NSAIDs 4 weeks prior to the study
11. Clinically significant cardiac, renal (creatinine \> twice normal) or liver disease
12. Alcohol use disorder (AUDIT\>8)
13. Chronic use of illicit drugs
14. Shift Work
15. Inability to sign an informed consen
The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis

Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage T3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy.
* without other malignant tumors;
* Those without serious heart, liver, kidney and other diseases;
* ECOG score: 0-1.

Exclusion Criteria:

* Complicated with ulcerative colitis or Crohn's disease;
* Complicated with severe organ insufficiency, severe diabetes, and heart disease;
* Pregnant and lactating women;
* Abnormal bowel movements with systemic and metabolic diseases;
* The patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month.
SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma

This is a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and more effective than treatment with SHR-1210 alone; and reverse the resistance of anti-PD-1 antibody in patients with HL who had previously treated with anti-PD-1 monotherapy. If it is deemed that the combination therapy is more efficacious than SHR-1210 monotherapy (The CR rate of the combination group is at least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in predicting 60 subjects naïve to anti-PD-1 antibody who are randomly assigned (2:1) to the above two groups), the stage II study will be revised to a multicohort, decitabine-plus-SHR1210 single-arm clinical trial. The primary objective of stage II study is to evaluate the long-term response duration with decitabine-plus-SHR-1210 in relapsed or refractory Hodgkin Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).

  2 12 to 75 years of age. 3 ECOG performance of less than 2. 4 Life expectancy of at least 3 months. 5 Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.

  6 Subjects must have received at least four prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.Subjects with Anti-PD-1 antibody are eligible which must be resistance.

  7 Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

* 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.

  2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.

  3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .

  4 Prior organ allograft. 5 Women who are pregnant or breastfeeding. 6 Women with a positive pregnancy test on enrollment or prior to investigational product administration.

  7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant

The current prospective clinical study's aim is to determine ABT's ICE implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of ICE implants.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over the age of 18 years who need implantation of 1-4 implants.
2. Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
3. Patients who had provided written informed consent to participate in the study prior to any study procedure.
4. Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.

Exclusion Criteria:

1. Immediate loaded implants.
2. Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
3. Treatment with anticonvulsants drugs.
4. Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
5. Patients with history of alcohol, narcotics or drug abuse.
6. Patients under steroid therapy.
7. Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.

   Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
8. Metabolic bone disorders and/or bone augmentation.
9. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
10. Degenerative diseases.
11. Osteoradionecrosis.
12. Renal failure.
13. Organ transplant recipients.
14. HIV positive.
15. Malignant diseases.
16. Diseases that compromise the immune system.
17. Unbalanced diabetes mellitus. (HbA1c above 6.5)
18. Psychotic diseases.
19. Hypersensitivity to one of the components of the implant in general and titanium in particular.
20. Women who are pregnant or lactating.
21. Lack of patient cooperation.
22. Uncontrolled endocrine diseases.
23. Any systemic condition that is unbalanced and therefore precludes surgical procedures.
24. Parafunctional habits.- e.g Bruxism.
25. Temporomandibular joint disease.
26. Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus ,malignancy of oral cavity, bolus erosive diseases of the oral mucosa.

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Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke

The purpose of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on motor cortex excitability in individuals who have suffered stroke and to study the influence of the phase of the oscillatory rhythm (mu frequency) on motor excitability in stroke individuals.

Neurological disorders, including stroke, are associated with impaired movement leading to significant negative effects on quality of life. Transcranial magnetic stimulation (TMS) is increasingly being explored as a rehabilitation strategy to enhance plasticity in motor regions.

However, it is not yet fully understood how TMS acts on motor circuits and what optimal stimulation parameters are. TMS is a noninvasive neuromodulation method which enables in vivo perturbation of neural activity in humans through the application of electromagnetic fields to the brain. TMS has an established safety profile and has been explored extensively in clinical trials for a range of neurological and psychiatric disorders. Particularly, in potential positive effects of TMS have been identified for stroke rehabilitation. However, significant variability in treatment outcomes across patients has been found, making it necessary to improve current stimulation protocols and to investigate basic mechanism of action . The investigators plan to study the effects of TMS to the motor cortex in individuals who suffered stroke for movement rehabilitation. The investigators plan to measure motor evoked potentials (MEPs) at different phases of the motor mu-rhythm measured with EEG. Mu rhythms are related to healthy movement execution. By this, the investigators characterize phase-dependent cortical excitability differences in stroke.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from chronic stroke, resulting in self-reported motor deficits (stroke occurring more than 6 months before study enrollment)
* Confident level of English language

Exclusion Criteria:

* Metal or electric implant in the head, neck, or chest area
* Upper extremity botulinum toxin treatment in the last 6 months
* Pregnancy or breastfeeding
* Prior occurrence of unprovoked seizure
Effect of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Men

This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men

The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 54 overweight middle-aged men. This study will be carried out in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and Phase 2 will assess the antibody response to influenza vaccination following almond consumption. Participants will attend a baseline clinic and will be randomized to one of two groups. The Almond group will receive 15% of daily energy intake in the form of almonds as a snack and the Control group will receive an isocaloric carbohydrate-based commercial snack (pretzels). The intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Overweight men (Basal Metabolic Index 25-32)
* Age limit between 40-65 years
* Be able to commute to Loma Linda University

Exclusion Criteria:

* Intolerance or allergy to almonds
* Bad dentures, inability to chew almonds
* Regular intake of almonds and or other nuts
* Use of immune boosting supplements
* Exposure to antibiotics and corticosteroids immediately prior to study
* Have received influenza vaccination in past 10 months
* Uncontrolled chronic disease and psychiatric illness
EUS Share-wave in Patients With Liver Cirrhosis

Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions.

The diagnostic work-up of patients with chronic liver disease includes less-invasive diagnostic methods such as abdominal ultrasonography, transient elastography, upper endoscopy; and more invasive procedures, mainly liver biopsy and portal pressure gradient measurement, both with associated risks.

Endoscopic ultrasound offers a benefit of including all diagnostic work-up in a single procedure. The investigators previously demonstrated that EUS-elastography of the liver and spleen is reliable marker for predicting liver cirrhosis.

Recently, a quantitative evaluation of fibrosis using share wave elastography was introduced, mainly for the pancreatic tumor fibrosis measurement (2). Elastography measures the elasticity of tissues (hardness); whereas share wave measures the tissue elasticity as the elastic modulus by measuring the share wave velocity. Share wave measurement will be performed with the Arietta 850 Endoscopic ultrasound console using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). The investigators proposed the EUS-share wave of the liver as a reliable diagnostic marker in patients with liver cirrhosis.

A non-blinded, prospective trial. Primary disease condition: liver cirrhosis Keywords: Liver Cirrhosis; Fibrosis; Endoscopic Ultrasonography; Elasticity Imaging, Tissue.

Study Design: Observational study model: a non-blinded, non-randomized, prospective trial Time perspective: prospective Enrollment type: actual Number of subjects: 16 participants Number of groups/cohorts: 2 cohorts Target follow-up duration: 6 months

Based on the proportion of patients with the liver strain histogram (LSH) \>87.40 among cirrhosis (87.5%) and control cases (31.0%) described by Robles-Medranda et al. (1), the investigators calculated eight patients per study group with a 5% and 20% of alpha and beta error respectively, with an 80% of power statistic.

Eligibility Criteria:
Inclusion Criteria:

* Provided informed written consent
* Age greater than 18 years of age
* Confirmed diagnosis of chronic liver disease based on transient elastography
* Patients with EUS-guided liver biopsy

Exclusion Criteria:

* History of uncontrolled coagulopathy
* Contraindications to EUS-guided liver biopsy
* Pregnancy or nursing
* History of hepatocellular carcinoma
* Patients with equivocal transient elastography results
Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy

Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG.

BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire.

In this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopy proven Buried Bumper Syndrome
* PEG or Jet-PEG

Exclusion Criteria:

* Major Coagulation disorder
* Percutaneous endoscopic jejunostomy or use of a ballon fixed device
The Effect of Breast Augmentation on the Quality of Echocardiography Test

Breast augmentation surgery is currently the most common elective plastic surgery performed in the US. With regards to the surgical technique, there are 4 incisional sites available for breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar, inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast tissue), submuscular (underneath the Pectoralis Major), or "dual-plane" (combination of both) manner.

Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation of cardiac structure and function. Its use has increased dramatically in the last decades. We have encountered three women with congenital heart disease who have undergone breast augmentation, and their echocardiographic images were significantly limited after the implantation. There is only one case report in the medical literature suggesting that breast implants interfere with echocardiographic views .

The underlying physical property of the silicone breast implants that causes interference with the ultrasound beam during echocardiographic examination is not known and has not been studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and unrevealing despite increase in gain or change in the ultrasound wave's frequency.

Many women elect breast augmentation for cosmetic reasons. Women with congenital heart disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire augmentation accordingly.

Knowledge of the extent of impairment of breast implants to the echocardiographic examination is important for few reasons:

1. Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation should be consulted as to the limitation of the echocardiographic examination following the procedure.
2. Women without heart disease considering breast augmentation should be informed of potential echocardiographic interference, if echocardiography be needed in the future,
3. Different surgical techniques may cause different masking effect.
4. Different implants size and shape may cause different masking effect.


Eligibility Criteria:
Inclusion Criteria:

1. 1. Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation

Exclusion Criteria:

1. Unwillingness to participate.
Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

The aim of the trial is to compare the efficacy of extracorporeal shock wave therapy (ESWT) versus neuromuscular training (TR) in reducing pain in women with patellofemoral pain (PFP). Women with PFP will be randomly divided into two therapeutic groups: ESWT and TR. The ESWT group will undergo extracorporeal shock wave therapy to the iliotibial band and tensor fascia latae. The TR group will be treated with neuromuscular training. The women's gait will be analysed and the strength of hip abductors and internal rotators will be measured. Additionally, the women's pain and health status will be assessed with the visual analogue scale and the Lysholm Scale. Outcomes will be registered at baseline, and then at five weeks and at three months post-therapy


Eligibility Criteria:
Inclusion Criteria:

Knee pain for more than three months greater than three on the visual analogue scale (VAS) during at least two out of four typical activities:

1. ascending or descending the stairs,
2. prolonged sitting with flexed knee,
3. running or jumping,
4. squatting or kneeling.

Exclusion Criteria:

1. Orthopaedic diagnosis other than PFP.
2. Patients with neurological disorders, history of injury or operations within the symptomatic leg, rheumatoid disease, or pregnancy were also excluded from the study.
TomVasc - Vascular Effects of Tomato Extract

Does tomato extract improve blood vessel function in healthy people and people with cardiovascular disease?

Atherosclerosis ('furring' of the arteries) affects the functioning of blood vessels, narrowing and eventually blocking them, causing conditions like heart attack and stroke. The Mediterranean diet, which is rich in tomatoes and tomato-based products, has been shown to be associated with a reduced risk of blood vessel damage. In this double blind, placebo-controlled randomised study, the investigators will investigate whether a food supplement containing a standardised extract of tomato improves blood vessel function in both healthy people (aged 40-80), and people with a history of cardiovascular disease. The food supplement is on sale to the public, and the investigators are testing the standard dose. Approximately 72 people will take part at the Clinical Pharmacology Unit at the ACCI Building, Cambridge University Hospitals NHS Trust.

After they have passed screening tests, participants will be allocated by chance to receive either the tomato extract product (Ateronon), or a matching placebo (a dummy capsule with no active ingredients), which they will take once a day for 8 weeks. At the beginning and end of the treatment period, the investigators will test blood vessel stiffness using an ECG machine and external probe. The investigators will also measure forearm blood flow, which involves infusing 3 separate agents that affect how the lining of the blood vessel wall works, and helps to assess whether this is affected by the study treatment. Blood tests will also be used to look at how the food supplement is working and its effects on cholesterol and markers of inflammation. Including the screening period, and a follow-up telephone call two weeks after the end of treatment, participants will be in the study for 14 weeks.


Eligibility Criteria:
HEALTHY GROUP

Inclusion Criteria:

* Aged between 30 and 80 years
* Non-smoking

Exclusion Criteria:

* Hypertension or other cardiovascular disease
* Significant renal, respiratory or neurological disease
* Diabetes mellitus
* BMI\>32, BMI\<18
* Use of vasoactive medication
* Use of heparin or warfarin
* Allergy/intolerance to study substance ingredients

STABLE CARDIOVASCULAR DISEASE GROUP

Inclusion Criteria:

* Aged between 40 and 80 years
* Previous ischaemic heart disease (any of previous myocardial infarction, coronary stent, angina), transient ischaemic attack or stroke disease or peripheral vascular disease
* If taking a statin, dose must have been stable over preceding 2 months

Exclusion Criteria:

* Uncontrolled hypertension
* BMI\>33
* Use of heparin or warfarin
* Allergy/intolerance to study substance ingredients