cyrilzakka/clinical-trials huggingface dataset:
Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)

The primary objective of this study is to monitor the safety and tolerability of vericiguat.


Eligibility Criteria:
Inclusion Criteria:

* Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the Week 52 visit and safety follow-up period for the VALOR base study.
* A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
* Is able to receive medication via the oral or gastric route .

Exclusion Criteria:

* Is hypotensive for age at Visit 1
* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
* Has undergone heart transplantation or has an implanted ventricular assist device.
* Has severe chronic kidney disease
* Has hepatic disorder
* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
* Has concurrent or anticipated use of an sGC stimulator.
* Is both ≥18 years of age and vericiguat is commercially available to the participant
Gut Microbiota and Multiple Sclerosis

Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.

Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system. The etiology of MS is complex and poorly understood. Both genetic and environmental factors play a role and recent evidence suggests that gut microbiota is one of the key environmental factors. Gut microbiota is increasingly being seen an important environmental risk factor for multiple sclerosis, and strategies to correct an imbalance in intestinal flora.The first study, "Multiple sclerosis patients have a distinct gut microbiota compared to healthy controls," published in Scientific Reports, found that people with relapsing-remitting MS have altered fecal microbiota and may have microbial dysbiosis. People with MS had reduced levels of a protein called aryl hydrocarbon receptor circulating in their blood.Aryl hydrocarbon receptor is involved in many biological processes, including inflammation. The researchers found that gut microbiota play a role in turning tryptophan, and amino acid found in food, into Aryl hydrocarbon receptor agonists, which act on cells of the nervous system called astrocytes and limit inflammation of the central nervous system. Low levels of Aryl hydrocarbon receptor in multiple sclerosis patients may explain how microbial dysbiosis could be causing the condition.Increased constipation and fecal incontinence and increased gut permeability in multiple sclerosis patients, and increased occurrence of inflammatory bowel diseases in MS patients and their families suggest an important gut-central nevus system connection.Interestingly, gut bacteria can also influence the blood brain barrier integrity. These studiesimplicate that gut microbiota may potentially be operational in predisposition to or modification of the disease course of multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* The study will included 40 cases of MS according to Diagnostic criteria of multiple sclerosis they classified into two types of Multiple sclerosis ,Relapsing-remitting MS (group 1), and Primary progressive MS, Secondary progressive MS, and Progressive relapsing MS (group 2).

Each patient was submitted to the following:

Expanded disability status scale score between 1 and 6 and functional system score.

Demographic and clinical data (Age, sex, age of onset, severity of disease, clinical symptoms and signs, Types of treatment, duration of treatment, number of attacks).

Exclusion Criteria:

* The general exclusion criteria included prior surgeries, any patients or controls currently taking antibiotics or probiotic supplements,or having a known history of disease with an disease such, rheumatoid arthritis,type-1-diabetes, and IBD, were also excluded from the study.Microbial DNA was extracted from fecal material of each sample.
Clinical Outcomes Study of the Nexel Total Elbow

The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

The objectives of the study are to confirm safety and performance of the Zimmer® Nexel™ Total Elbow when used in primary or revision total elbow replacement by analysis of standard scoring systems, radiographs, and adverse event records.

The safety of the device will be monitored using the frequency and incidence of reporting adverse events.

The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older.
* Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.
* Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:

  * Elbow joint destruction which significantly compromises daily living activities
  * Post-traumatic lesions or bone loss contributing to elbow instability
  * Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis
  * Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain
  * Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
  * Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
* Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.

Additional Retrospective Arm Inclusion Criteria

* Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.
* Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted.

Exclusion Criteria:

* Patient has a currently active or history of repeated local infection at the surgical site.
* Patient has a current major infection distant from the operative site.
* Patient has a history of prior sepsis.
* Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
* Patient has significant ipsilateral hand dysfunction.
* Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.
* Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and/or competitive sports.
* Patient is a prisoner.
* Patient is mentally incompetent or unable to understand what participation in the study entails.
* Patient is a known alcohol or drug abuser.
* Patient is anticipated to be non-compliant.
* Patient is known to be pregnant.
Vegan Diet, Amla Fruits and Uric Acid

This is an intervention study aiming to test the effectiveness of a vegan diet, My Plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels.

Ninety-two participants with hyperuricemia will be randomly assigned to one of these 4 diet interventions: (1) vegan, (2) vegan with amla fruits, (3) my plate-low purine, (4) my plate-low purine with amla fruits. During the 3 months intervention phase, participants will attend group lessons and individual nutrition counseling sessions to assist adherence to the diet. At baseline, end of 3 months, and 1 year, participants will be measured on uric acid and other cardiometabolic risk factors, and some nutritional markers. Amla fruits powder, and some foods encouraged in each dietary arm will be provided to enhance adherence during the 3 months intervention phase.

Eligibility Criteria:
Inclusion Criteria:

* Men with serum uric acid \> 7mg/dL
* Women with serum uric acid \> 6mg/dL
* Willing to make diet changes according to dietary interventions

Exclusion Criteria:

* Age \<19
* With cancer diagnosis
* With diseases that require special dietary needs
* On urate-lowering medication within 3 months
Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

The purpose of this pilot study is to obtain a preliminary assessment of the effect of VK supplementation on cognitive performance and vascular function in adults with stable Coronary Heart Disease (CHD)

The overall goal of this study is to obtain a preliminary assessment of the effect of a VK1 (phylloquinone) supplementation on cognitive performance (primary outcome) and vascular function (secondary outcome) in adults with stable CHD. Specifically, the investigators will conduct a double-blind, 2-armed, parallel-group intervention study in which 40 men and women aged 60 years and over with stable CHD will be randomly assigned to 0.5 mg phylloquinone per day or matching placebo for a period of 3 months. All participants will have signed a written consent form before taking part in the study

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 60 years and older
* Medically documented stable Coronary Heart Disease (CHD)
* Daily dietary intakes of phylloquinone \<150 mcg
* Non-consumption of vitamin K supplements (i.e. K1 or K2, singly or in combination with other nutrients), or other cognitive aids
* Good French or English understanding
* Physical exercise not exceeding 2.5 hours/week of moderate to vigorous aerobic activity
* Capacity and willingness to sign informed consent

Exclusion Criteria:

* Recent acute coronary syndrome (\<3 months) or recent coronary revascularization (bypass surgery or percutaneous coronary intervention, \<3 months)
* Known left ventricular dysfunction (LVEF \< 40%) or chronic heart failure
* Recent modification of medication (\<2 weeks)
* Warfarin (Coumadin) use
* Cognitive impairment (based on telephone version of the Mini-Mental State Examination test, score \<19/23)
* Diagnosis of depression or uncontrolled anxiety
* Malabsorption disorder (advanced liver disease, Crohn's disease)
* Patient with auditory or vision impairments not properly corrected by glasses or hearing aids
* Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer

This study aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.

In 2005, since Yamada reported the first case of laparoscopic completion total gastrectomy (LCTG) for RGC, laparoscopic technology was widely used in the treatment of RGC. However, due to the low incidence and rapid aggravation of RGC, adhesion, anatomic changes, and more complex lymphatic pathways caused by the previous operation, the popularity of LCTG is limited. Therefore, higher level evidence is warranted to further confirm the safety, feasibility, and oncological outcomes of LCTG in patients with RGC. This prospective single-arm study is designed to evaluate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

Age between 18 and 75 years; Carcinomas arise in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or the method of reconstruction; cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 7th Edition; Performance status of 0 or 1 on ECOG scale; ASA class I, II, or III; Written informed consent.

Exclusion Criteria:

Distant metastasis in the preoperative examinations; Previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection); Other malignant diseases (except gastric cancer) within the past 5 years; Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes; Women during breast-feeding or pregnancy; Severe mental disorder; Unstable myocardial infarction, angina, or cerebrovascular accident within the past 6 months; History of continuous systematic administration of corticosteroids within one month; FEV1\<50% of predicted values; Requirement of simultaneous surgery for other disease; Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer.
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Female age 25 - 55
* Subject agrees not to use any hand wash products on their hands other than what has been provided in the study.
* Subject agrees not to use any moisturizers or any skin products on their hands during the study
* Subject agrees to use gloves to protect hands from activities such as dish washing
* Subject is willing to sign the Informed Consent and HIPAA
* Subject agrees to comply with the study requirement

Exclusion Criteria:

* Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands
* Subject has scaly skin on hands based on Visual Scoring Scale at Day 1
* Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves)
* Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study
* Subject is pregnant
* Study coordinator believes the subject is unsuitable for inclusion in the study
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin.

Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.


Eligibility Criteria:
Inclusion Criteria:

* A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated MRI scans or ≤ 2 mm distance to chiasma opticum, or:
* a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma

Exclusion Criteria:

* Clear indication for surgery at the time of inclusion
* Previous radiation therapy
* Pituitary surgery the last 6 months
* Previous apoplexy/bleeding in the adenoma
* Pregnancy or lactation
* Contraindications for cabergoline treatment (Known cardiac valvular disease, known pulmonal, pericardial or retroperitoneal fibrosis, clinical significant liver insufficiency, use of medications that interact with cabergoline
* unfit to participate due to any other reason
Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring

The purpose of this study is to develop and validate the performance of an artificial intelligence(AI) assisted Boston Bowel preparation Scoring(BBPS) system for evaluation of bowel cleanness, then testify whether this new scoring system can help physicians to improve the quality control parameters of colonoscopy in clinic practice.

Colonoscopy is recommended as a routine examination for colorectal cancer screening. Adequate bowel preparation is indispensable to ensure a clear vision of colonic mucosa，complete inspection of all colon segments, and furthermore improves the detection rates of small adenomas. Thus, the adequacy of bowel preparation should be accurately evaluated and documented. However, the accuracy of current bowel preparation quality scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. While, no studies have been conducted to evaluate the performance of deep learning algorithm in bowel preparation quality scoring. This study aims to train an algorithm to assess bowel preparation quality using the BBPS, and testify whether the engagement of AI can improve the quality control parameters of colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

• Patients aged 18-70 years undergoing afternoon colonoscopy

Exclusion Criteria:

* Known or suspected bowel obstruction, stricture or perforation
* Compromised swallowing reflex or mental status
* Severe chronic renal failure(creatinine clearance \< 30 ml/min)
* Severe congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* Dehydration
* Disturbance of electrolytes
* Pregnancy or lactation
* Hemodynamically unstable
* Unable to give informed consent
Tooth Loss in Periodontitis Patients

Tooth loss in periodontitis patients is associated with patient and site factors as well as with treatment provided. Not much is known about long-term tooth loss in periodontitis patients in private practice in the UK. The study plans to follow-up 200 subjects with periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment provided, site and patient risk factors on tooth loss will be studied.


Eligibility Criteria:
INCLUSION CRITERIA:

1. Initial diagnosis of chronic or aggressive periodontitis (Lindhe et al. 1999, Lang et al. 1999), with at least two sites with PPD and CAL ≥5mm
2. Diagnosed and treated by the same periodontist (LN)
3. Willing to give written informed consent for study participation
4. Willing to undergo SPT as per standard of care for at least 5 years

EXCLUSION CRITERIA:

1. Serious medical history that prevents patients from undergoing dental treatment
2. History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
3. Current alcohol or drug abuse
4. Self-reported pregnancy or lactation
5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may compromise trial participation and/or interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial
Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

This is a Phase 1/2, open-label, dose-ascending, multicenter study of the safety and efficacy of LX2006 for participants who have Friedreich's Ataxia with evidence of cardiomyopathy. The study will evaluate up to three doses of single administration of LX2006 (AAVrh.10hFXN), an adeno-associated virus (AAV) gene therapy designed to intravenously deliver the human frataxin (hFXN) gene to cardiac cells over a 52-week period. Long-term safety and efficacy will be evaluated for an additional 4-years for a total of 5-years post LX2006 treatment.

Friedreich's ataxia (FA) is a rare, autosomal recessive disease caused by a mutation in the autosomal frataxin (FXN) gene. Progressive cardiomyopathy with cardiac hypertrophy and fibrosis is observed in most individuals with FA. The disease is more severe in those with earlier onset. Presently, there is no therapy that alters the progression of cardiomyopathy in FA, which is responsible for 59% of FA-related deaths.

The primary objective of this dose escalation study is to assess the safety and tolerability of three ascending doses of LX2006 in patients with FA-associated cardiomyopathy. LX2006 is designed to restore hFXN levels in order to improve mitochondrial function. Assessments of cardiac function, biomarkers and other preliminary efficacy endpoints are also included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed genetic diagnosis of FA, with onset being before 25 years of age
* Protocol specified ranges for antibodies
* Protocol specified measures of FA cardiomyopathy

Exclusion Criteria:

* Protocol specified ranges for left ventricular ejection fraction (LVEF) as measured by cardiac ECHO
* Uncontrolled diabetes
* Abnormal liver function
* Active infection of any type, including hepatitis virus (A, B or C) or human immunodeficiency virus (HIV-1 and HIV-2)
* Contraindication to cardiac MRI
* Contraindications to cardiac biopsies
* Participants who are receiving systemic corticosteroids or other immunosuppressive medications
* History of significant coronary artery disease or any structural heart or vascular disease other than FA cardiomyopathy
* Presence of clinically significant, hemodynamically unstable arrhythmias, requiring physician intervention
* Presence of clinically significant abnormalities as determined by the investigator, other than ECG abnormalities related to FA
* Uncontrolled psychiatric disease

Other Inclusion/Exclusion criteria to be applied as per protocol.
Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users

The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* 20 to 85 years of age
* RA, OA, or low back pain
* taking oral diclofenac sodium over 3 months
* No change of drugs before 3 months
* under 5 mg of corticosteroid use
* CRP \< 1mg/dl

Exclusion Criteria:

* known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
* prostaglandins, metronidazole or salazosulfapyridine
* can not swallow
* with pacemaker
* after gastrointestinal operation
* serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
* any other conditions that the investigator feels would interfere with data interpretation or create under risk