cyrilzakka/clinical-trials huggingface dataset:
The Oral Microbiota is Associated With Autoimmune Thyroiditis

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial disorders such as autoimmune thyroiditis However, there is no report on the relationship between oral microecology and autoimmune thyroiditis. Therefore, our group will study the correlation between oral microbiota and AITD.

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbiological disorders. Intestinal microelements Both ecology and oral microecology belong to the category of microorganisms. It has been reported in the literature that intestinal microecology occurs disorder of autoimmune thyroiditis. However, there is no report on the correlation between oral microecology and autoimmune thyroiditis. When oral microbe flora When the immune system is disrupted, the immune balance is broken, the immune system is over-active, and the autoimmune disease (AID) is lost to the autoantigens and non-pathogenic commensal microbial flora antigens, including rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, inflammatory bowel disease, and allergic diseases. However, the association between oral microbial flora and AITD remains unclear. . Therefore, the research group will carry out the correlation between oral microbial flora and AITD.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* GD was clinical diagnosed and thyroid function returned to normal
* HT was clinical diagnosed and thyroid function is normal.

Exclusion Criteria:

* Pregnancy
* Lactation
* Cigarette smoking
* Alcohol addiction
* Hypertension
* Diabetes mellitus
* Lipid dysregulation
* BMI \> 27
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
* History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
* History of malignancy or any gastrointestinal tract surgery
Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)


Eligibility Criteria:
Inclusion Criteria:

* Male of female subjects, 18-65 years of age with a diagnosis of SPMS
* HLA DR2 and/or DR4 positive
* Absence of a relapse in the 3 months prior to baseline
* EDSS of 3.0 - 6.5

Exclusion Criteria:

* Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline
* Treatment with Tysabri within 2 years of baseline
* Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly

Other protocol-defined inclusion/exclusion criteria may apply.
Bronchial NIR Image-guided Resection

This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.

Patients enrolled in the study will undergo peritumoral injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery. ICG injection will be carried out via navigational bronchoscopy, CT-guided or trans-thoracic ICG injection (dependent on lesion location) and ICG imaging of the sentinel lymph nodes will be undertaken using an NIR-enabled camera.

* This study is designed primarily to determine the safety and feasibility of intra-operative localization of thoracic lesions following ICG injection, and second, to include an assessment of the predictive value of sentinel lymph nodes relative to the disease status of the greater lymphadenectomy specimen as well as disease recurrence rates.
* We are using a dose approximately 100 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will look at these lymph nodes with near-infrared fluorescence and then remove any fluorescent and non-fluorescent lymph nodes near the tumor, as is standard for lung surgery.
* The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lymph nodes most likely to contain tumor cells. If the lymph node is not found in the group of nodes usually removed, we will use the near-infrared light to look near the tumor for the sentinel lymph nodes and guide the surgeon so that the sentinel nodes can be removed and studied. The surgeon will then continue with the operation and remove the tumor. The lymph nodes are processed for special analysis tailored to finding metastasis in sentinel lymph nodes.
* As is standard of care, patients will be monitored for evidence of recurrence by their surgeon. Recurrences will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.
* 18 years of age or older
* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Exclusion Criteria:

* Pregnant women are excluded and women of childbearing potential without a negative pregnancy test prior to study procedures. All patients with Iodine allergies will be excluded.
Health and Wellness After Preterm Birth

This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.

Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within 4 weeks of birth.The primary outcome of this study is acceptability and feasibility of the intervention and study procedures as measured by the Acceptability of Intervention Measure, participant completion of study data collection, and interventionist completion of planned intervention modules.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 14 - 45
* History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. )
* Intention to seek pediatric care at one of two pediatric primary care sites
* Medicaid insurance

Exclusion Criteria:

* History of sterilization procedure.
* Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
* Limited English proficiency.
* History of organ failure or malignancies.
Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration

The goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2 (obesity class II and III)
* Gastroesophageal reflux disease and/or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)
* ASA status I-III
* NPO for 8 hours before the study

Exclusion Criteria:

* Chronic kidney disease or End-stage renal disease
* Diabetes Mellitus
* Use of any medication that affects gastric secretion or emptying within the past 24-hour
* Pregnancy
* History of major upper gastrointestinal surgery
* Allergy to ultrasound gel
Phase 2 Chronic Low Back Pain Study

The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.

Eligibility Criteria:
Inclusion Criteria:

Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

Exclusion Criteria:

Subjects with a history of surgical or invasive intervention
Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

The goal of this clinical trial is to \[primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.\] in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main question\[s\] it aims to answer \[is/are\]:

Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population?

Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response.

Participants will be asked to:

* Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily.
* Participate in 8 study visits over 52 weeks
* Complete questionnaires
* Have an endoscopy with biopsies and EndoFLIP measurements.
* Swallow an Esophageal String Test


Eligibility Criteria:
Inclusion Criteria:

* Seen at CHCO for clinical care.
* Age 12 - 25 years old inclusive
* Weight ≥40 kg at the time of screening visit
* Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
* Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
* Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)

Exclusion Criteria:

* Esophageal dilation performed at index endoscopy
* Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
* Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
* Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
* Patients who have received dupilumab in the past 12 months for any indication are excluded.
* Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.
* Patients with a fasting morning cortisol \<5 within 2 months of screening will not be enrolled. If repeat cortisol levels are normal, patients can be reconsented.
* Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.
* Patients with a known gelatin allergy will be excluded from EST collection.
Cohort Study of Endometriosis at Different Sites

To present the clinical characteristics of pelvic or extra-pelvic endometriosis and explore the potential risk factors of pathogenesis and recurrence by comparing patients with endometriosis at different sites

Endometriosis is a chronic inflammatory disease defined as the presence of endometrial glands and stroma outside of the internal epithelial lining of the cavum uteri, affecting up to 10% of reproductive age women. It is rarely found in extrapelvic locations.This form of endometriosis may be difficult to diagnosis due to pleomorphic presentation. Despite complete excision with a safe margin and histopathological examination has been considered as definitive diagnosis and primary therapeutic treatment for extra-pelvic endometriosis, what is understood mainly comes from case reports and retrospective observations with limited number of cases. Moreover, approximately 6%-14% of patients with PEM who had underwent narrowly operative resection still suffered recurrent lesions, while risk factors were barely identified.

Patients with endometriosis at different sites in our hospital were collected for analysis of clinical characteristics namely demographic information, medical history, surgical records, pathological and imaging reports, serum levels of cancer antigen 125 (CA125), peri-operative medication. During long-term follow-up, prognosis of individuals could be identified by telephone or clinical interview. Based on data from medical records or clinical observation, risk model predicting recurrence will be established by comparing patients with different outcomes or exposed to different risk factors. Thus, management of endometriosis might be improved. Hopefully, pathogenesis of recurrent and primary endometriosis might be explained.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were clinically diagnosed with endometriosis at different sites (pelvic and/or extra-pelvic) and received surgical treatment at PUMCH

Exclusion Criteria:

* i). underwent bilateral oophorectomy in the operation, ii). had incomplete records of inpatient management, iii). had no post-operative outpatient follow-up, iv). combined with malignancy.
CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease

The prevalence of OSA (Obstructive sleep apnea，OSA) is 2%-4% in general population and 16%-47% in surgical-heart failure patients. Our previous study found that OSA was associated with the increasing incidence of perioperative adverse events.The continuous positive airway pressure (CPAP), as the standard treatment for OSA, is extensively applied clinically. The previous study reported that postoperative AHI was reduced and SPO2 was increased by CPAP treatment. However, whether CPAP treatment can improve OSA postoperative and related adverse events or not in patients with rheumatic valvular heart diseases (RVHD) were not reported.The purpose of this study is to observe the effective of preoperative CPAP on postoperative sleep parameters and adverse events, such as AHI changes, duration of ICU stay and duration of mechanical ventilation.

Between December 1, 2017 and June 30 2019, 200 patients with chronic heart failure caused by rheumatic valvular heart disease waiting for heart valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography (PSG). Of them, 30 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (15:15).

The CPAP treatment group received both baseline and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline treatment.

Preoperative Sleep parameters (AHI, mean and lowest SPO2) and clinical evaluations including NYHA class, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded.

Operation related parameters such as duration of operation, duration of cardiopulmonary bypass and bleeding volume were recorded.

Postoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubation are recorded.

A PSG was re-examined before discharge from hospital. The changes of AHI, mean and lowest SPO2 between pre- and post-operative PSG parameters were calculated.

The operation related parameters, postoperative adverse events and the changes of sleep parameters were compared between CPAP and non-CPAP patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-75 years.
2. Patients with rheumatic valvular heart disease.
3. Patients combined with obstructive sleep apnea (apnea-hypopnea index \>=5/h).
4. Received heart valve replacement surgery.
5. The enrolled patients having received patients' informed consent.

Exclusion Criteria:

1. History of stroke or clinical signs of peripheral or central nervous system disorders.
2. History of Chronic obstructive pulmonary disease or asthma.
3. Enrolment in another clinical study.
Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection

Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity and there are proofs of relation between patients with recurrent infections and lack of MBL, we decided to explore a possible relation between low levels of MBL and different genotypes of MBL in young women and the risk to develop recurrent UTI.


Eligibility Criteria:
Inclusion Criteria:

* women above 18 years old.
* premenopausal
* recurrent UTI

Exclusion Criteria:

* pregnancy
* immunocompromised
* active malignancy
* HIV carrier
The Genetic Effects on Vitamin D Supplementation

Vitamin D is essential for skeletal growth and bone health, deficiency causes rickets and osteomalacia. In the UK 29% of adults have vitamin D deficiency. It is recommended all adults take 10µg vitamin D supplement daily. Genetic variations could alter vitamin D status by affecting vitamin D metabolism. Systematic reviews found variations in VDR, GC and CYP2R1 genes are associated with vitamin D deficiency. This study aims to assess the effects between vitamin D supplementation and variations in VDR, GC and CYP2R1 genes on vitamin D status.

The study design is a quantitative, randomised control trial measuring vitamin D concentrations in blood serum. All participants will be given the recommended 10µg daily dose of vitamin D supplementation. Participants will be grouped based on their genotype for each gene, as either low, medium or high-risk genotypes. The low-risk group will act as a control and the medium and high-risk groups will act as the intervention groups.

Participants will attend St Mary's University's applied science laboratory twice. During their first visit participants will provide a 2ml capillary blood sample. Blood samples are collected using lancets to prick participants' ear lobes. The serum is extracted from the blood samples, serum is stored at -80c until analysis. Participants will be given 90 10µg vitamin D supplements and instructed to take one per day for 90 days. Participants will also be instructed to not make any major changes to their habitual diet. During the second visit participants will provide 1 ml of saliva sample into the Collection Pot and a second 2ml sample of blood. Serum samples will be analysed for vitamin D concentrations using 25(OH) Vitamin D ELISA kit. DNA will be extracted from the saliva samples using PSP SalivaGene DNA Kit following the manufacturer's protocol. DNA will be genotyped for variations in the VDR, GC and CYP2R1 genes. Data will be assessed to determine if variations in these genes influenced the effectiveness of vitamin D supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* female and male
* 18-65 years
* completion of physical activity readiness questionnaire (PAR-Q).

Exclusion Criteria:

* Below 18 years
* above 65 years
* individuals taking medications that could interact with vitamin D status
* Individuals regularly taking daily Vitamin D supplementation during the 3 months before the intervention start date
* major dietary changes in vitamin D intake during the intervention period
Outcome of the Treatment of Flexor Tendon Injuries

In order to gather enough data for meaningful statistics, a multicenter register of all flexor tendon repairs was established with surgical, clinical and rehabilitation patient data. The controlled active motion (CAM) protocol was administered in all patients after surgery. The purpose was to (i) measure surgery and therapy outcomes in the three centers and (ii) evaluate potential influencing factors on outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Injury between 2014 and 2025
* Flexor tendon injury of the fingers or thumb in zones 1-3

Exclusion Criteria:

* No given consent
* Concomitant injuries as fractures, large soft tissue injuries, replantation
* Bony avulsion fracture of flexor tendon (Jersey finger)
* Basic disease as rheumatoid diseases
* Primary and secondary tendon reconstruction and tendon transfer