cyrilzakka/clinical-trials huggingface dataset:
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
* Prior failure of conservative therapy and ODI Score \>20%.
* Radiologic evidence of LSS (L3-L5), Ligamentum flavum \>2.5mm, confirmed by pre-op MRI and/or CT.
* Central canal cross sectional area ≤ 100 square mm.
* Anterior listhesis ≤ 5.0mm.
* Able to walk at least 10 feet unaided before being limited by pain.
* Available to complete 26 weeks of follow-up.
* A signed Informed Consent Form is obtained from the patient.
* Adults at least 18 years of age.

Exclusion Criteria:

* Prior surgery at intended treatment level.
* History of recent spinal fractures with concurrent pain symptoms.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.)
* Significant / symptomatic disc protrusion or osteophyte formation.
* Excessive / symptomatic facet hypertrophy.
* Bleeding disorders and/or current use of anti-coagulants.
* Use of ASA and/or NSAID within 5 days of treatment.
* Pregnant and/or breastfeeding.
* Epidural steroids previously administered (not ESI naive)
* Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
* Dementia and/or inability to give informed consent.
* Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.).
* On Workman's Compensation or considering litigation associated with back pain.
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery

This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.


Eligibility Criteria:
Inclusion Criteria:

* Planned single cataract extraction with lens implant
* Best-corrected visual acuity of 20/200 or better in the opposite eye

Exclusion Criteria:

* Glaucoma or history of intraocular hypertension in the study eye
* History of chronic ocular allergy in the last year requiring treatment
* Scheduled for cataract surgery in the non-study eye during study participation
PET MRI as a Staging Tool for Head and Neck Cancer

To explore the use of PET/MRI in the staging and pretreatment evaluation of patients with head and neck cancer and to compare this modality to standard PET/CT imaging.

This study is a prospective clinical study whereby an emerging technology, PET/MRI will be compared to a more standard imaging modality, PET/CT, using newly diagnosed head and neck cancer patients as subjects. PET/MRI will also be used in this study to explore the merits of this new technology in determining extent of disease, functional impact, and potential treatment outcome.

In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria. Once accepted as a candidate for the study, the newly diagnosed head and neck cancer patients will undergo both PET/CT and PET/MRI imaging within one week of each other. These studies will then be reviewed by a radiologist specializing in Head and Neck radiology familiar with PET imaging. The studies will be compared for any imaging differences. The imaging findings will then be correlated with pathological findings after surgery to determine if there are any consistent findings that correlate with adverse pathological findings, if found.

The specific imaging data points to be determined by a radiologist will be tumor and metastatic disease size, SUV uptake, specific anatomic structures involved with tumor, imaging irregularities and characteristics of those imaging irregularities of the involved structures locally and regionally (if present), imaging characteristics of the different phases of MRI (T1, T2, etc.), and any other notable imaging characteristic.

Eligibility Criteria:
Inclusion Criteria:

* Active head and neck cancer that require PET/CT regardless of the point of treatment
* TNM staging I or II

Exclusion Criteria:

* Patients whose primary treatment option is chemotherapy or radiation therapy (not surgical)
* Implanted pacemakers
* Intracranial aneurysm clips
* Cochlear implants
* Certain prosthetic devices
* Implanted drug infusion pumps
* Neurostimulators
* Bone-growth stimulators
* Certain intrauterine contraceptive devices; or
* Any other type of iron-based metal implants.
* MRI should not also be used on persons with the presence of internal metallic objects such as bullets or shrapnel, as well as surgical clips, pins, plates, screws, metal sutures, or wire mesh.
* Subject with breast tissue expanders.
Retrospective Analysis of Results of Surgery for Deep Bowel Endometriosis

identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after surgery, pregnancy, live birth, additional surgery, spontaneous conception, conception by IUI, ART


Eligibility Criteria:
Inclusion Criteria:

* deep Infiltrating endometriosis, surgery with complete or partial resection of bowel endometriosis or conservative Management, Treatment at endometriosis Center University Hospital Muenster, Germany, wants to participate

Exclusion Criteria:

* declines participation
Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.

The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histological or clinical diagnosis of cirrhosis.
* HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
* Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or naïve patients with decompensated cirrhosis (Child-Pugh score ≥ 7) who had contraindicated the antiviral treatment.
* Presence of compensated or decompensated (Stage A, B or C according to the Child-Pugh Classification).
* Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.

Exclusion Criteria:

* Age less than 18 or greater than 70 years.
* Presence of uncontrollable clinical or biochemical complications related to severe liver failure (hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, serum bilirubin level greater than 5 mg/dL, international normalized ratio greater than 2.5).
* Active alcoholism.
* Serum creatinine greater than 2 mg/dL.
* Hepatocellular carcinoma.
* Refusal to participate in the study.
* Concomitant disease with reduced life expectancy.
* Severe psychiatric conditions.
* Co-infection with hepatitis A or B or HIV.
* Drug dependence.
* Pregnancy.
Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services

Family planning and the use of contraceptive methods are of the main strategies to reduce maternal and perinatal morbidity and mortality, because they can prevent unplanned pregnancies, teenage pregnancies and abortions in dangerous conditions. It is also a tool that contributes to development as it improves children's health, improves access to early childhood education, empowers women and contributes to reducing poverty as it improves economic conditions.

Currently the use of modern contraceptive methods has increased worldwide, in Latin America and the Caribbean the use of modern contraceptive methods has remained at 66.07% from 2008 to 2015. However, the number of women who do not want to get pregnant and that do not use a contraceptive method is still high - 214 million women of childbearing age in developed countries.

In our country according to the ENDES 2016 survey, the number of women who used a contraceptive method decreased by 0.7 percent compared to 2012, of which 54.3 percent used some modern contraceptive method and 21.9 percent some method traditional.

The unmet demand for family planning in 2016 was 6.0%, affecting mainly women from the lowest poverty quintile (7.4%) and those living in rural areas (6.8%).

Of the women who were surveyed and did not use a contraceptive method, 80.6% did not talk about family planning either at home or in a health facility in the last 12 months. Only 16.3% of non-users were women who attended a health facility and received information on family planning.

Through this study the investigators propose the design and evaluation of an interactive platform to promote modern contraceptive methods.

Sample Size: Sample size of 176 participants (interventional group=88, control group=88), it is possible to detect minimum differences of 5% to 20%.

Statistical analysis plan: The data collected will be entered into a database in Microsoft Excel, to be analyzed by the Epi Info statistical program. The qualitative variables will be analyzed by frequencies and percentages, the quantitative variables by relative risk.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of children who attend the service of growth and development who are of legal age
* Women who do not currently use some modern contraceptive method
* Women whose partners have not received voluntary surgical contraception

Exclusion Criteria:

* Teen mothers
* Illiterate women
* Women who currently do not have a partner
* Women who are currently gestating
Evaluation of mediVR-KAGURA Guided Therapy

The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.

The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld controllers in a motion-tracked three-dimensional space called "room scale" of the mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users with \>90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology.

First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. Horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 \* maximum reaching distance, 0.9 \* (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. A falling object disappeared at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. By thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training.

The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation programs will be personalized.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with physical and/or cognitive dysfunctions
2. Agreed to the participation of this study with written informed consent by themselves or guardians

Exclusion Criteria:

1. Inappropriate candidates at attending physician's discretion
Extended Delivery of Bupivacaine Study in Herniorrhaphy

This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia
* Has an American Society of Anesthesiologists Physical Status of I, II, or III
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives.

Exclusion Criteria:

* Had any prior inguinal hernia repair
* Has a planned concurrent surgical procedure
* Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken any NSAIDs within least 10 days prior to the scheduled surgery
* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting)
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments
* Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C
* Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives
* Has undergone 3 or more surgeries within 12 months
* Has a body mass index (BMI) \>39 kg/m2.
Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms

This groundbreaking human study on the ASD microbiome includes probiotic clinical trials, investigation of treatment biomarkers, machine learning/deep learning platform development for ASD classification and prediction, and identification of diagnostic biomarkers. Upon completion, the investigators anticipate publishing at least 12 SCI papers and/or patents and establishing an auxiliary diagnosis platform for both clinical and academic purposes. The findings will offer new insights into the pathogenetic mechanisms, improving early detection, diagnosis, and treatment, ultimately advancing precision medicine for ASD.

With an increased prevalence of autism spectrum disorder (ASD) worldwide and in Taiwan, ASD demands urgent attention due to its lasting impact, unclear causes, and limited diagnostic and treatment options. Recent studies highlight disruptions in the gut-brain axis, particularly in ASD. Building on PI Gau's prior research on altered gut microbiota in autism spectrum disorder (ASD), this proposed 4-year study aims to develop evidence-based probiotic intervention (GKB7) and treatment biomarkers for behavioral interventions (Naturalistic Developmental Behavioral Interventions, NDBI, and Program for the Education and Enrichment of Relational Skills, PEERS®) through comprehensive assessments. The ultimate goal is to establish probiotic treatments and diagnostic/treatment biomarkers for ASD utilizing a deep-learning multimodal auxiliary platform.

Specific Aims:

S.I To conduct a randomized, double-blind, placebo-controlled trial to assess the treatment effects of Clostridium butyricum GKB7 on ASD.

S.II To investigate the effect of NDBI intervention trials using metagenomics as the outcome measure.

S.III To evaluate the effect of PEERS® interventional trials with metagenomics as the outcome measure.

S.IV To develop an artificial intelligence (machine/deep learning) multimodal auxiliary prediction platform that integrates environmental, behavioral/clinical, neurocognitive/imaging, and metagenomic data for ASD diagnosis, subtyping, and impairment prediction.

S.V To identify microbiome and metabolomic biomarkers and endophenotypes of ASD, and to establish Gut-Brain-Behavioral Axes in ASD.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 4 to 15 who are clinically diagnosed with ASD according to DSM-5 criteria and confirmed by the ADI-R/ADOS.
* Caregivers cooperate with all the assessments and stool and blood collection.

Exclusion Criteria:

* A history of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression), neurological disorders, and substances use disorders.
* Difficulty following instructions.
* Consumption of antibiotics and yogurt or probiotic products two weeks prior to enrollment.
Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women

In this randomized, placebo-controlled, double-blind study, we aim to investigate if the active product consisting of a probiotic blend can improve the quality of life and alleviate symptoms in peri- and postmenopausal women, using validated questionnaires.

Fifty to 80% of women around menopause or already in postmenopause complain about symptoms such as hot flashes, night sweats, sleep disturbances, tiredness, and depression, which negatively impact their quality of life. The aim of this study was to evaluate the effects of a multiprobiotic strain on the quality of life and menopause-associated symptoms. The study is a de-centralized, prospective, randomized, placebo-controlled, double-blind study in which peri- and postmenopausal women will be recruited and randomly assigned (ratio 2:1) to receive either a probiotic blend or placebo formulation in capsules form for 12 weeks. We aim to recruit up to 300 women. On a monthly basis, quality of life will be evaluated by using the validated Spanish Quality of Life Cervantes questionnaire. In addition, other questionnaires will be administered to monitor menopause-related symptoms (Menopause Rating Scale, MRS) and health-related quality of life (Utian Quality of Life). This will be documented through a specifically designed, web-based platform. Main study variable is change in the global score in MRS scores and Cervantes quality of life scores throughout study period.

Eligibility Criteria:
Inclusion Criteria:

1. Women in peri- and/or postmenopause period (up to 5 years after last menstruation) Perimenopause is defined as if changes in the menstrual cycle (such as longer or shorter cycles, absence of any menstrual cycle, or abnormally heavy or prolonged bleeding) have occurred in the previous 12 months.
2. Age 45-60 years.
3. Cervantes quality of life scale score ≥ 38 at the screening visit.
4. Willing to sign the informed consent.
5. Willing to maintain dietary or lifestyle habits during the study.

Exclusion Criteria:

1. Regular use of probiotics other than the probiotics under study (in the form of food supplements or in foods such as "bifidus" type yogurt) in the month prior to the baseline visit.
2. Use of oral or injectable antibiotics in the last month before the start of the study.
3. Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
4. Diagnosis of active oncological disease.
5. Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
6. Type 1 diabetes.
7. Untreated or unstable thyroid disease.
8. Diagnosis of severe renal, cardiac or hepatic disease.
9. Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
10. Diagnosis of celiac disease
11. Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
12. Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.
Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis

For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an alternative to UCEIS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of ASC according to Truelove and Witt's criteria;
2. Patients were generally able to tolerate the flexible colonoscopy before start of CS treatment;

Exclusion Criteria:

1. Patients with incomplete colonoscopy, inadequate fecal sample;
2. Patients with indeterminate diagnosis of ASC (colorectal cancer, Crohn's disease) according to colonoscopy;
3. Patients with infectious colitis, Clostridium difficile and CMV infection, primary immunodeficiency, recent history of immunosuppressant within 3 months.
4. Patients with bowel resection, intestinal anastomotic, and ileum enterostomy.