cyrilzakka/clinical-trials huggingface dataset:
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery

The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 89 years of age
* Patients undergoing primary arthroscopic meniscus surgery

Exclusion Criteria:

* Patients age less than 18 or greater than 89 years
* Illiterate or non-English speaking patients
* Patients with contraindications to ketorolac
* History of drug or alcohol abuse
* Chronic use of analgesic or psychotropic drugs
Myocardial Fibrosis, Function and Aging

In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as diastolic function is reported to change according to age. The objective is to explore the relationship between myocardial function changes, with local (T1 and diffusion) fibrosis measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin auto-fluorescence and collagen blood-biomarkers).


Eligibility Criteria:
Inclusion Criteria:

* physical activity ≤ 3 x(30') per week
* no history of smoking, diabetes, myocardial infarction, heart failure, hypertension (\<140 or \<90 mmHg) and no anti-hypertensive or cardiovascular-related medications
* no familial history of early myocardial ischemia
* body mass index (BMI) \<30kg/m2
* normal routine lipid blood analysis
* glycemia \<1.26g/l
* normal electrocardiogram (ECG)

Exclusion Criteria:

* arrhythmia
* hepatic insufficiency
* pregnancy
* claustrophobia
* MRI contrast allergy,
* general contraindications to MRI such as pacemaker, etc.
Niclosamide In Moderate COVID-19

This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for treatment of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.
* Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day.
* SARS-CoV-2 infection confirmed by RT-PCR in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
* Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

* At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
* Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?

Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Colonic transit time is an important determinant of intestinal generation and uptake of bacterial metabolites. However, it is unknown if accelerating the colonic transit time reduces the intestinal generation and uptake of indoxyl sulfate and p-cresyl sulfate. Prucalopride is a selective, high-affinity 5-HT4 receptor agonist with a stimulating effect on colonic motility and transit. It is currently used in treating chronic slow-transit constipation. An observational study will be initiated in non-chronic kidney disease patients with chronic slow-transit constipation necessitating treatment with prucalopride to observe its effect on serum concentrations and intestinal generation of indoxyl sulfate and p-cresyl sulfate.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 85 years
* Chronic slow-transit constipation as defined be 4 criteria:

  1. having two or fewer spontaneous complete bowel movements week for a minimum of 6 months
  2. having one or more of the following symptoms for at least one-quarter of the time: lumpy/hard stools, a sensation of incomplete evacuation, or straining during defecation.
  3. slow transit time as determined by Rx colon transit study ("pellet")
  4. without evidence of secondary constipation or primary defecation disorder
* Need of therapy with prucalopride (i.e., inefficacy of dietary changes and laxatives)
* Follow-up visit possible after 4 weeks of treatment
* Written informed consent

Exclusion Criteria:

* History or new diagnosis of organic intestinal disease (e.g., inflammatory bowel disease, malignancy)
* Secondary constipation (drug-induced, endocrine, metabolic or neurological disorders, surgery, known or suspected organic disorders of the large intestine, or megacolon) or primary defecation disorder
* Use of laxatives two days before start of treatment and during treatment period. If there is no spontaneous bowel movement during 3 consecutive days, rescue treatment with bisacodyl and/or enema is allowed if necessary
* Presence of significant co-morbidity (uncontrolled heart, liver and lung disease)
* Pregnancy
* Chronic kidney disease, i.e., estimated glomerular filtration rate (MDRD) \< 60 ml/min/m² or need of dialysis therapy
Efficacy of an Automatic Toothbrush

The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.

Primary endpoint: difference in "full mouth plaque score" between before and after brushing.

Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.

Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.


Eligibility Criteria:
Inclusion Criteria:

* Absence of fixed orthodontic appliances
* Presence of at least 20 teeth
* Full mouth plaque score greater than 40%
* Having provided signed and dated informed consent.

Exclusion Criteria:

* Subjects with manual inability to perform normal oral hygiene maneuvers
* Subjects allergic to silicone or nylon.
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease

A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Eligibility Criteria:
INCLUSION

* Health Status

  1. Healthy volunteers must be in good health
  2. Celiac Disease must be well controlled and in good health
* Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.
* Body Mass Index (BMI) of \< 30 kg/m2,

EXCLUSION

* A positive urine test for alcohol or illegal drugs at screening.
* The subject has received an experimental drug within 30 days of the present study.
* History of substance abuse, within the last 5 years
* Clinically significant abnormal lab values, as determined by the PI
* Alcohol consumption of \> 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration.
* history of any medically significant condition considered by the PI to adversely affect participation in the trial
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have

  * entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
  * completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
* Sexually active patients of childbearing potential agree to use birth control
* Females of childbearing potential must have a negative urine pregnancy test prior to dosing
* Lactating females must agree not to breastfeed
* Patient must meet protocol criteria for CC or IBS-C

Exclusion Criteria:

* Patient must not use protocol-defined prohibited medicine
* Patient is planning to receive an investigational drug at any time during the study
* Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges

The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system during meal challenges.


Eligibility Criteria:
Inclusion Criteria:

* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
* Have a body mass index of 18.5 to 37 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months
Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications

Some undesirable complications such as pain, swelling, trismus, paresthesia, hematoma, infection and, albeit rare, fractures may occur after lower impacted wisdom tooth surgery. More effective wound closure methods with fewer complications have positive effects on postoperative recovery. Suturing is the most commonly used wound closure technique after lower impacted wisdom tooth surgery. Suturing, which is the last step of the operation, contributes to wound healing in order to reposition and stabilize the tissue components and to control bleeding. In our study, it was aimed to evaluate the efficacy of silk and polyester sutures used in wound closure techniques, which are frequently used in lower impacted wisdom teeth surgery.

This randomized, single-blind, split-mouth study was carried out on 30 patients who applied to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery. Silk suture was used on one side of the patients and polyester suture was used on the other side. When the patients first applied to the clinic, their anamnesis was taken and panoramic images were taken after clinical evaluations were made.

Evaluations were made with preoperative face measurements (for evaluation of swelling), maximum mouth opening (for evaluation of trismus) and periodontal measurements for all patients. The mentioned measurements and evaluations were repeated on the 2nd and 7th postoperative days. In addition, postoperative pain was evaluated with the VAS scale.

The same surgical procedure was performed by the same surgeon for all patients. After local anesthesia (2ml of 80 mg Articaine hydrochloride + 0.02mg Epinephrine bitartrate) a 3-corner flap containing the vertical incision passing through the mesial of the number 7 was lifted, the bone removed under saline cooling and the teeth were separated when needed. Afterwards, the extraction sockets will be irrigated with saline to control bleeding, and the area is closed primarily with silk or polyester suture material.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years and over
* Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell \& Gregory classification,
* Asymptomatic impacted teeth,
* Individuals who is coming to control and fill in the given and requested forms,
* Individuals with an operation time of 30 minutes or less

Exclusion Criteria:

* Systemic disease,
* Smoking,
* Pregnancy or breastfeeding,
* Allergy to the drugs to be used in the study,
* Using any additional medication that may affect the outcome of the study,
* Using medication until 2 weeks before the operations,
* Post-operative alveolitis.
Lipoprotein and Apolipoproteins With Metabolic Liver Diseases

Theranostic translation applications against viral, metabolic liver diseases and hepatic oncogenesis: lipoprotein and apolipoproteins at a crossroad

An intimate link between microbial infections, metabolic changes and oncogenesis has been drawn attentions increasingly, indicating a crossroad leading to pathogenesis and disease progression. Globally the burden of hepatitis B and C virus infections is 450 and 185 millions, respectively and chronic hepatitis disease causes a high risk of liver cirrhosis, hepatocellular carcinoma and metabolic disorders

Eligibility Criteria:
Inclusion Criteria:

1. above 20 years
2. nonalcoholic fatty liver disease
3. Non-Alcoholic Steatohepatitis

Exclusion Criteria:

1. alcohonic hepatitis 2. Autoimmune liver disease 3. HIV postive

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Assessment of Risk in Chronic Airways Disease Evaluation

Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular disease is a major cause of death in such patients and it may be related to excess stiffening of the walls of major arteries, such as the aorta, and it has been suggested to represent premature aging. However, there is little known of the development of these problems, which were previously considered to be due to smoking and which is now known not to be the only factor. The investigators will study a large group of patients with mild to very severe airflow obstruction based on the NICE 2010 classification of severity and a matched comparator group free of COPD. This study involves three assessments of the development of the complications of COPD over a five year period. The key measure will be the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in wall stiffness will be related to the severity of lung disease; other known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular events including heart attacks and death; and to the presence of other complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the context of changes in bodywide inflammation and metabolic function and the changes in the rate of ageing. This increased knowledge of interacting factors in the complications of COPD is likely to lead to studies of treatments to avoid their development.


Eligibility Criteria:
Inclusion Criteria:

* Previously Proven COPD or at risk of developing COPD

Exclusion Criteria:

* Pregnancy
* A history of malignancy in the last 5 years
* Unable to give informed consent or diagnosed dementia
* Renal or hepatic failure
* Active endocrine disorder eg., Addison's disease, hypothyroidism
* Any other disease identified as having an inflammatory or metabolic component, eg. rheumatoid disease
* Disorders affecting mobility, eg. Parkinson's disease, cerebrovascular accident.
Cardiovascular Magnetic Resonance Guided Open Artery Trial for Revascularization of Late Presenting ST Elevation Myocardial Infarction

Patients with STEMI are usually treated with primary PCI in contemporary practice. However, primary PCI is currently deemed unbeneficial or potentially harmful in patients presenting late after a STEMI. There is limited data to suggest that patients who may have viable myocardium despite presenting late with a STEMI may derive benefit from PCI, which may be denied in current practice. CMR imaging is the reference modality for assessment of left ventricular function and myocardial viability. This feasibility study will randomise late presenting STEMI patients with CMR documented viability to PCI plus optimal medical therapy (OMT) versus OMT alone. The investigator hypothesises that PCI in this cohort will improve left ventricular remodelling and function. Favourable results will lead to an adequately powered multi-centre trial with the potential to improve the management of late resenting STEMI patients and impact on clinical practice guidelines.

Stable patients with late presenting STEMI will be prospectively recruited into this study from 5 large primary PCI centres in the UK. Ethical approval from a Research Ethics Committee and written informed consent from all participants will be obtained.

Recruited patients will receive baseline CMR to detect viability within 7 days of index admission or coronary angiogram. Patients with non-viable myocardium will be treated with standard clinical care and form part of the registry arm. Patients with viable myocardium will be randomised to revascularization with OMT vs OMT alone. PCI will be performed according to standard techniques using newer generation drug eluting stents. All patients will recieve dual anti-platelet treatment for 12 months, or as per local practice guidelines. other treatments will be given according to evidence based guidelines. Revascularization wth CABG can also be considered, based on MDT decision.

The feasibility study will randomise 60 patients (30 in PCI and 30 in OMT group). OAT-NUC trial showed that 70% late presenting STEMI may have viability. therefor, recruiting 90 patients for baseline CMR may provide 60 patients to randomise. the results of this feasibility study will inform the investigator of the numbers needed for an adequately powered multi-centre clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients presenting \>12 hours, and within 28 days, after symptom onsent.
* Stable patients with no on-going features of ischaemia (chest pain, dynamic ECG changes)

Exclusion Criteria:

* Inability to give informed consent
* Standard CMR contra-indications
* Haemodynamic instability (requiring on-going intravenous therapy or respiratory support)
* Previous coronary artery bypass grafting and cardiomyopathy
* Estimated glomerular filtration rate \<30ml/min/1.73m2
* End-stage malignancy or expected life expectancy of less than 12 months.
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair

Management of non-vital primary molars is challenging due to the natural anatomy of primary teeth, patients' young age, and their behavior toward dental treatment. A simple and effective technique such as Lesion Sterilization and Tissue Repair offers a solution to cases with poor prognosis; however, the medicaments used in this technique have some limitations. This study will evaluate three different medicaments regarding the clinical success, radiographic success, and antibacterial activity.

This randomized controlled trial will include 108 non-vital mandibular primary molars in children aged 4-8. Patients will be randomly allocated into three groups according to the studied medicaments as one positive control group and two experimental groups. The groups are as follows:

Group I (conventional double antibiotic paste) positive control group Group II (double antibiotic paste-loaded chitosan-coated silver nanoparticles) experimental group Group III (chitosan-coated silver nanoparticles) experimental group

The antibacterial activity of studied medicaments will be tested against Enterococcus Faecalis bacteria in planktonic and biofilm forms. Teeth will be evaluated clinically and radiographically to obtain baseline data. After local anesthesia administration and isolation of teeth, an access cavity will be performed, then the medicament will be placed over the floor of the pulp chamber according to the corresponding group. Afterwards, teeth will be filled with resin-modified zinc oxide and eugenol followed by stainless steel crowns. Blinded clinical evaluation will be done at baseline, 1, 6, and 12 months and blinded radiographic evaluation will be done at baseline, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy cooperative children of both sexes in the age range of 4-8 years old.
* Children with consenting parents who accept to participate in the study and sign the consent forms.
* Children with mandibular primary molars with clinical and radiographic signs of pulpal necrosis.

Exclusion Criteria:

* Children with hypersensitivity to any of the used medicaments.
* Non-restorable teeth without sufficient coronal structure for placement of rubber dam isolation and restoration with stainless steel crowns
* Non-restorable teeth with perforated pulpal floor