cyrilzakka/clinical-trials huggingface dataset:
Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis

This study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (OCD) through performing an integrated analysis of gut microbiota, serum metabolomics, neuroimaging and electroencephalography (EEG), conducted before and after treatment with selective serotonin reuptake inhibitors (SSRIs). The results will be compared with those of pediatric OCD paitents comorbid with tic disorder (TD) and healthy controls. The findings are expected to further elucidate the potential pathogenesis of OCD, providing a theoretical basis for identifying novel clinical intervention targets and optimizing treatment strategies.


Eligibility Criteria:
We recruited outpatient children and adolescents with OCD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (4th edition). The following inclusion and exclusion criteria were also applied:

Inclusion Criteria:

(1) 7-17 years old, (2) Y-BOCS score ≥16, (3) with or without a history of TD, (4) Drug-naïve or drug-free for 8 weeks, (5) Wechsler IQ score ≥ 80.

Exclusion Criteria:

* History of serious medical, neurological illness or other psychotic disorders other than OCD (tic disorder excepted).
* Previous exposure to cognitive behavioral therapy (CBT) for OCD or TD.
* serious suicide risk.
* Has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within the past 8 weeks.
* Has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus.
* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?

Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.

Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.

A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.

Study and treatment periods

1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant)

Measurements and Procedures:

Assessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms).

Women with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned.

* Assessment of symptoms at 3 months only (bleeding calendar and satisfaction questionnaire, see below)
* Assessment of willingness to receive implant at 3 months in OD+ESI group data collection is limited to these items, in order to limit burden on participants, and to focus resources on high quality of data (as opposed to quantity).

Eligibility Criteria:
Inclusion criteria:

* Women age of 18 - 42 years
* Interested in the use of ESI
* Accepting to have 90 days pre-treatment with OD
* Signed informed consent

Exclusion criteria:

* Pregnancy
* Lactation,
* vaginal bleeding of unknown origin,
* wish to become pregnant,
* weight over 80 kg,
* history of deep vein thrombosis/Pulmanory embolism,
* hypertension,
* Diabetes or other metabolic diseases,
* coagulation disorders,
* severe hepatic disorder,
* history of breast/endometrial cancer,
* known hypersensitivity to study drug,
* current treatment with enzyme inducing drugs (e.g.: phenytoin, carbamazepine, phenobarbital, etc.)
Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
* patients who gave written informed consent from patients or responsible family members.

Exclusion Criteria:

* patients who take pain killer within 48 hours or regularly at enrollment
* confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
* multiple gastric lesions for ESD
* history of gastric surgery at enrollment
* severe underlying disease including infection, cardiopulmonary disease, and diabetes.
Clinical Evaluation of the Infinity Deep Brain Stimulation System

The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components.

Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to provide informed consent;
* Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN), or has received an implant of an Infinity system with bilateral lead implants in the STN;
* Subject must be available for follow-up visits.

Exclusion Criteria:

* Subject is not a surgical candidate;
* In the investigator's opinion, the subject is unable to tolerate multiple programming sessions within a single setting;
* Subject is unable to comply with the follow-up schedule.
Midline Programme - Vascular Nursing Team

Integration of the Vascular Nursing Team of the Department of Haematooncology, University Hospital Ostrava for the needs of all clinical departments of the hospital. Assessment of local signs of inflammation in patients of the Department of Haematooncology and other clinical departments of the University Hospital Ostrava.

The study subjects were indicated by a physician for Midline catheter insertion.

Prior to insertion of the catheter, the study subjects were fully informed and signed the informed consent with participation in the study.

Local signs of inflammation were recorded in the study subjects, together with basic demographic characteristics (age, sex, diagnosis), and complications during catheter insertion, the number of days when the Midline catheter was inserted, number of changes of the dressings, presence of neutropenia in the study subjects and the score of local inflammation according to Madonna.

* Degree 0- no pain or reaction in the surrounding
* Degree 1 - pain only, no reaction in the surrounding
* Degree 2 - pain and reddening
* Degree 3 - pain, reddening, swelling or painful stripe along the vein
* Degree 4 - puss, swelling, reddening and painful stripe along the vein The investigators also observed on which day the first signs of infection appeared.

Eligibility Criteria:
Inclusion Criteria:

* insertion of Midline catheter by nurses from the Vascular Nursing Team
* age over 18 years

Exclusion Criteria:

- inability to insert the Midline catheter
Effects of Non-surgical Periodontal Therapy on Severe Periodontitis and Hyperlipidemia

This study was a single-center, non-randomized, parallel-group design clinical trial, and each group was assigned a 1:1 ratio with or without hyperlipidemia. Both groups underwent periodontal non-surgical treatment, and blood and gingival crevicular fluid were collected before surgery, 1 month and 3 months after surgery for the detection of MCP-1, IL-8, oxLDL, TNF-α, TG, LDL-C, HDL-C.

This study was a single-center, non-randomized, parallel-group design clinical trial, and each group was assigned a 1:1 ratio with or without hyperlipidemia. Both groups underwent periodontal non-surgical treatment, and blood and gingival crevicular fluid were collected before surgery, 1 month and 3 months after surgery for the detection of MCP-1, IL-8, oxLDL, TNF-α, TG, LDL-C, HDL-C.MCP-1, IL-8, oxLDL, TNF-α will be tested for concentration using ELISA.

Eligibility Criteria:
Inclusion Criteria:

* Subjects had to meet at least one of the following criteria for the diagnosis of hyperlipidemia: triglyceride (TRG) levels \>2.26 mmol/L; high density lipoprotein cholesterol (HDL-C) levels \<1.04 mmol/L; or low density lipoprotein cholesterol (LDL-C) levels \>4.14 mmol/L
* Patients with severe periodontitis (stage III/IV) with probing depth (PD) ≥ 6 mm at at least six sites, at least two multi-rooted or two single-rooted teeth in at least one quadrant, and extended bone loss on imaging to the middle or top third of the root. Periodontitis results in the loss of less than or equal to four teeth.

Exclusion Criteria:

* systemic illnesses
* pregnancy or lactation
* systemic antibiotics taken within the previous 6 months
* use of cholesterol reduction medication during the past 6 months
* subgingival scaling and root planing or surgical periodontal therapy in the last year
* chewing smokeless tobacco, smoking pipes or cigars 1 or more times per week, or smoking more than 20 cigarettes per week (1 pack per week) in the past 6 months
National Register Studies in Thoracic Surgery

The overall project aim is to study risk and outcomes following thoracic surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

The purpose of this research project is to study risks and outcomes in patients who underwent thoracic surgery, primarily for lung cancer. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish quality register for thoracic surgery (ThoR) and other national health-data registers maintained by the government agencies Statistics Sweden and the National Board of Health and Welfare. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers.

Specifically, we aim:

1. To analyze the association between socioeconomic factors and prognosis in patients undergoing pulmonary resection for lung cancer.
2. To investigate the implementation of minimally invasive surgery for lung cancer in Sweden.

Eligibility Criteria:
Inclusion Criteria:

All adult patients who underwent thoracic surgery in Sweden during the study period

Exclusion Criteria:

-
Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI

Establish a deep learning model based on multi-parameter magnetic resonance imaging to predict the efficacy of neoadjuvant therapy for locally advanced rectal cancer.This study intends to combine DCE with conventional MRI images for DL, establish a multi-parameter MRI model for predicting the efficacy of CRT, and compare it with the DL and non-artificial quantitative MRI diagnostic model constructed by conventional MRI to evaluate the role of DL in MRI predicting CRT. And this study also tries to build a DL platform to assess the efficacy of LARC neoadjuvant radiotherapy and chemotherapy, accurately assess patients' complete respose (pCR) after CRT, and provide an important basis for guiding clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proved rectal adenocarcinoma
* The first MRI diagnosis was locally advanced rectal cancer (LARC)
* Age 18-70
* Underwent magnetic resonance examinations twice
* Preoperative neoadjuvant chemoradiotherapy was completed
* Complete total mesangial resection of rectal cancer and postoperative pathological examination
* Informed consent and signed informed consent form

Exclusion Criteria:

* Poor magnetic resonance image quality, such as severe artifacts
* Cases complicated with intestinal obstruction or perforation requiring emergency surgical treatment
* Previous treatment for rectal cancer
* A history of other malignant tumors
* A history of abdominal and pelvic surgery
* Patients were lost to follow-up and voluntarily withdrew from the study due to adverse reactions or other reasons
The Influence of Health Information in Stretch Break Program Participant's Lifestyle

Objective: To verify the influence of information passed during anthropometric assessment would have in physical exercise (PhE) and eating habits of 14 participants (female=11; 51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative approach. Were applied, between March and May of 2010, anthropometric evaluation and semi-structured interviews. During the evaluation were provided information and guidance on health.


Eligibility Criteria:
Inclusion Criteria:

* FUPb white collar workers of either gender

Exclusion Criteria:

* Anyone who did not complete anthropometric measurements
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.


Eligibility Criteria:
Inclusion Criteria:

* Moderately obese with hyperlipidemia

Exclusion Criteria:

* Recent unstable heart or lung condition
* Current use of other lipid modifying drugs
* Hepatic disease
* Pregnancy or lactation
Indole-3-Carbinol Effects on Estrogen Metabolism

This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.


Eligibility Criteria:
Inclusion Criteria:

* woman aged from 30 - 50 years
* regular menstrual cycle

Exclusion Criteria:

* taking hormone replacement or hormonal contraception
* thyroid disorder
* uncontrolled asthma
* BMI under 18.5
* allergy to cruciferous vegetables
Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients

The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Gallbladder stones
* At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
* Higher risk (\>70yrs, \>60yrs with co-morbidity, \>50 with BMI\>40)

Exclusion Criteria:

* Not fit for general anaesthesia
* Cholangitis requiring emergency ERCP
* Previous upper GI surgery making ERCP impossible
Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators

Professional societies recommend that endoscopists measure their ceacal intubation rate, adenoma detection rate as indicators of the screening colonoscopy quality. However, it is uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in the detection of adenomas. The investigators hypothesize that a hands-on-training intervention tailored to the results of environmental assessment and audit on colonoscopy quality indicators results in higher adenoma detection rate improvement than simple audit and feedback. The investigators further hypothesize that by training the leaders of the screening centres, the effect of the intervention will be further disseminated among other endoscopists from the participating centers, and will thus result in additional increase in individual adenoma detection rate.

The primary aim is to compare the impact on adenoma detection rate of two screening colonoscopy improvement programs:

1. Tailored training intervention.
2. Audit feedback on colonoscopy quality indicators.


Eligibility Criteria:
Inclusion Criteria:

* screening center leading colonoscopist
* at least 30 screening colonoscopies in the 2011 edition of the screening program
* adenoma detection rate lower than 25%

Exclusion Criteria:

* lack of participation in the 2012 edition of the screening program
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool

The purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with Latina, Black, and non-Latina White women. The investigators will collect feasibility data and assess the use of the decision support tool with end-users. The aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.


Eligibility Criteria:
Inclusion Criteria:

* Latina, Black, or non-Latina White women
* Between the ages of 40-49 years
* Can write, read, and understand English

Exclusion Criteria:

-Women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following:

* Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ \[DCIS\], or lobular carcinoma in situ\[LCIS\])
* Self-reported personal history of atypical hyperplasia
* Self-reported first degree family member with history of breast cancer (e.g., mother, sister)
* Self-reported known underlying genetic mutation such as a BRCA1/BRCA2 gene
* Self-reported prior thoracic or chest wall radiation therapy
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.

Prospective, single-arm, multicenter early feasibility study

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. MR ≥ 3+
3. NYHA functional class ≥ II
4. High risk of cardiovascular surgery
5. Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
2. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
3. Significant risk of LVOT obstruction
4. Severe right ventricular dysfunction
5. LV Ejection Fraction \<30%
6. Patient is inoperable
7. Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
8. Need for aortic, tricuspid or pulmonic valve replacement
9. Presence of mechanical aortic valve prosthesis
10. History of cardiac transplantation
11. History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
12. Clinically significant untreated coronary artery disease requiring revascularization
13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
14. Stroke or transient ischemic attack within 90 days of the procedure
15. Myocardial infarction within 30 days of the procedure
16. Active bacterial endocarditis within 180 days of the procedure
17. Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
18. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
19. Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
20. Irreversible, severe pulmonary hypertension
21. Patients with renal insufficiency or receiving renal replacement therapy
22. Liver disease or significantly abnormal liver function test results
23. Refusal of blood products
24. Female who is pregnant or lactating
25. Estimated life expectancy \< 12 months
26. Participating in another investigational drug or device study