cyrilzakka/clinical-trials huggingface dataset:
Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers

The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.

In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..

This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)

Eligibility Criteria:
Inclusion Criteria:

* no systemic diseases
* women were not pregnant or breastfeeding status
* no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.
* all selected teeth were mandibular molar or mandibular premolar.

Exclusion Criteria:

* systemic and/or periodontal disease;
* allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;
* requirement for antibiotic prophylaxis
* open tooth apex
* pacemaker use
CYPRESS Efficacy and Safety Study Extension

This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.


Eligibility Criteria:
Inclusion Criteria:

* Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
* Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
* Willingness to participate in the trial for up to 3 years without contact lens wear;
* The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

* Known allergy to proparacaine, tetracaine, or tropicamide.
Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements

Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients with chest pain and dyspnea.

Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending on the assay. High-sensitivity assays measure concentrations that are ten-times lower than earlier generations of assays. However, the time from when troponin is elevated in the bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully known.

During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to do a short, controlled occlusion of coronary artery by inflating a small balloon in one of the coronary arteries. Numerous earlier studies in patients have used this method for induced occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured troponin I.

The aim with this study is to quantify and compare the release of troponin T and troponin I in the early hours after a controlled induced ischemia.

Study Design This is a prospective, descriptive and experimental study. There will be included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4 groups.

0: 10 patients - control group, no balloon occlusion

1. 10 patients - balloon occlusion for 30 seconds
2. 10 patients - balloon occlusion for 60 seconds
3. 10 patients - balloon occlusion for 90 seconds

Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6 hours: Every 30 minutes

Statistics This is a pilot study and it is estimated that ten patients are sufficient number of patients in each group to assess elevation of troponin after occlusion of coronary artery. The thesis is there is a dosage-response correlation between the length of balloon occlusion and the concentration of troponin in blood stream.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age Elective coronary angiogram Informed signed accept

Exclusion Criteria:

* Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin \> 100 µmol/L Heart Failure or LVEF \< 50 Severe Heart Valve Disease
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28 will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill at least one of the following criteria for dermatomyositis:

  1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
  2. ACR/EULAR criteria (Lundberg et al, 2017)
* Disease activity/severity fulfills at least one of the following three criteria:

  1. MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale \[VAS\]) and MMT-8 score ≤ 142 (out of 150 total possible)
  2. Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
  3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of \> 14
* Stable doses of immunosuppressive medications for DM as defined by:

  1. Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
  2. Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening

Exclusion Criteria:

* Unstable DM or DM with end-stage organ involvement at Screening or Visit 1
* Significant diseases or conditions other than DM that may influence response to the study drug or safety
* Any of the following values for laboratory tests at Screening:

  1. A positive pregnancy test (or at Visit 1)
  2. Hemoglobin \< 9 g/dL in males and \< 8 g/dL in females
  3. Neutrophils \< 1.0 × 10\^9/L
  4. Platelets \< 75 × 10\^9/L
  5. Creatinine clearance \< 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients

The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C infection.

This is a Phase 2, randomized (The study medication is assigned by chance.), 5-arm, open label (All people know the identity of the intervention.), multicentre (study conducted at multiple sites) study. Approximately, 84 participants will be randomized to 5 different arms in a 2:2:1:1:1 ratio. In treatment arms 1 and 2, participants will receive 12 weeks of triple therapy (use of 3 medications) with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin followed by 12 weeks of treatment with Peginterferon Alfa-2a and Ribavirin. In treatment arms 3 and 4, participants will receive 24 weeks of triple therapy with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin. In treatment arm 5 (control group), participants will receive Peginterferon Alfa-2a and Ribavirin for 48 weeks. This study will consist a screening phase of upto 6 weeks, treatment phase of upto 48 weeks and a post treatment follow-up period of 24 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and cardiovascular safety.

Eligibility Criteria:
Inclusion Criteria:

* Participants with documented chronic hepatitis C infection as evidenced by presence of HCV antibody at least 6 months (180 days) prior to the informed consent. - Participants with genotype 1 HCV infection. - Participants with plasma HCV RNA level of ≥ 5.0 log10 IU/mL at screening.

Exclusion Criteria:

* Participants diagnosed with hepatic cirrhosis or hepatic failure. - Participants with any other liver disease than hepatitis C. - Participants with infection/co-infection with non-genotype 1 HCV.
Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

The aim of this study is to investigate the continued usage of standard diabetes medications in the post operative period following bariatric surgery to determine whether this approach may improve long term diabetes control. At present, the standard of treatment in patients with type 2 diabetes is that all medication is stopped in the immediate postoperative period and only re-started if symptoms of diabetes re-emerge. Although a large proportion of patients with diabetes will initially go in to remission, 80% experience relapse within five years. This study is needed to determine whether continuing medications is not only safe but will improve long term outcomes for patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* eligible for bariatric surgery according to NICE guidelines (GC 189)
* Type 2 diabetes mellitus
* BMI \>30kg/m2

Exclusion Criteria:

* Recent hospitalisation in the past 30 days
* Recurrent hypoglycaemic episodes
* Recurrent hypotensive episodes
* Contraindications to bariatric surgery
* Previous bariatric surgery
* Current pregnancy
* Breastfeeding
ADAMTS-13 and Von Willebrand Factor Levels and Activities in Children With Cirrhosis and/or Portal Hypertension

Hemostasis-related disorders are common in cirrhosis and portal hypertension. However, it is not known whether the net effect of changes in hemostasis in the sense of predisposition to hemorrhagic or thrombotic state. It is suggested that increasing the concentration and activities of Von Willebrand factor (vWF) and decline ADAMTS-13 (A Disintegrin and Metalloproteinase with Trombospondin type 1 motif, member 13) may cause thrombophilic changes in cirrhosis and portal hypertension. The aim of this study was to investigate the changes in ADAMTS-13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) and von willebrand factor (vWF) levels and activities in patients with cirrhosis and portal hypertension.

Patients of 3 months to 18 years of age, followed-up or newly diagnosed in pediatric gastroenterology unit, who had cirrhosis or non cirrhotic portal hypertension included to the study. Written informed consent obtained from the parents and/or patients. The subjects was grouped in three. The first group consisted of patients with cirrhosis (with or without portal hypertension). The second group consisted of patients with non-cirrhotic portal hypertension (developed due thrombosis of portal vein). The last group consisted of healthy volunteers.

2 ml of EDTA blood was taken from the patients and healty volunters. Samples will be tested for vWF and ADAMTS-13 levels and activities at the end of the study.

The clinical scoring methods, PELD, MELD and Child Pugh scores, treatments received by patients, data from endoscopic, radiological screening, and blood analysis of patients were recorded.

Eligibility Criteria:
Inclusion Criteria:

• Patients with cirrhosis or portal hypertension aged 3 months to 18 years.

Exclusion Criteria:

* Being treated with fresh frozen plasma in the recent month.
* Patients previously diagnosed with bleeding diathesis.
* The patients who consumed vitamin K in the recent three weeks.
* Patients previously diagnosed with another chronic disease (such as renal failure, heart failure etc).
* Patients who suffer from acute or chronic infectious diseases.
Acute Lymphoblastic Leukemia Registry at Asan Medical Center

The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

1. Acquisition of informed concent form
2. Data acquisition from medical record including

   * demographic / disease-associated factors
   * details of treatment, and its results
   * complications during treatment
   * genetic data
   * survival outcome (upto 10 years)
3. Accumulation of data for 30 years
4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)

Eligibility Criteria:
Inclusion Criteria:

* All patients who are diagnosed and/or treated as acute lymphoblastic leukemia at Asan Medical Center (including biphenotypic acute leukemia with Philadelphila-positive, Burkitt leukemia/lymphoma)
* 15 years of age and over
* All patients who give written consent according to guidelines at Asan Medical Center committee on human research

Exclusion Criteria:

* Patients who refuse to give consent to registering
Inferior Vena Cava Filters: Analysis of a Database

In this study a retrospective analysis of patients database was performed, who underwent treatment for deep vein thrombosis in tertiary hospital by using inferior vena cava-filters

The aim of this research was to assess the cava-filter implantation frequency in a tertiary hospital with venous thromboembolism treatment center.

A retrospective analysis of patient's database was performed, who underwent treatment in the tertiary clinic between 2016 - 2017. In total, 2399 patients with venous thromboembolism were hospitalized, 442 cava-filters were implanted (239 in 2016 and 203 in 2017), which accounted for 18.4% of patients with venous thromboembolism. Removable cava-filters models were used in most cases (98.8%). Contraindications for anticoagulation were reason for cava-filters implantation in 119 (26.9%) cases, and in 184 patients (41.6%) cava-filters were implanted due to the inefficiency of anticoagulation. 38 (8.6%) patients with deep vein thrombosis (DVT) and pulmonary embolism had pulmonary hypertension of the 2nd to 3rd degree, which caused the implantation of cava-filters .

The occlusion of the inferior vena cava and cava-filters verified in 116 (26.9%) patients after cava-filters implantation, based on repeated ultrasound. The overall mortality rate in the group of patients with venous thromboembolism was 0.25% (6 patients), 5 of them (1.1%) underwent cava-filters implantation. The cause of all lethal outcomes was the progression of the underlying disease. During the next hospitalization 29 (6.5%) of implanted filters were endovascularly removed.

There are 18.4% of patients with venous thromboembolism undergoing cava-filters implantation for various reasons in a tertiary hospital. At the same time, occlusion of the inferior vena cava and cava-filters in the early post implantation period is observed in 26.9%. However, without clear criteria for the differentiation of cava-filters embolism from its thrombosis, we cannot assess whether this was a complication, or if the cava-filters completed its task by preventing pulmonary embolism. Thus, the validity of implanting cava filters question in terms of efficiency and safety remains unanswered, which poses the task for deep study of this problem and thorough analysis of the indications for the cava-filters implantation.

Eligibility Criteria:
Inclusion Criteria:

* Anticoagulation therapy contraindicated
* Anticoagulation therapy ineffective
* High pulmonary embolism risk (floating thrombus in proximal location)
* Deep vein thrombosis/pulmonary embolism together with high pulmonary hypertension(\>50 mm.Hg)
Autogenous Grafts for Anterior Maxillary Horizontal Ridge Augmentation

The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for anterior maxillary horizontal ridge augmentation.

Autogenous block graft has been used as onlay thin cortical shell and cortico-cancellous particles. The thin cortical shell acts as an autogenous biological membrane that will resist resorption and stabilize the small pieces of particulate bone. The bone block is screwed-in at a distance from the recipient site by means of titanium bone screws, and then the free space under the shell is filled with the particulate bone.

The resultant augmentation somehow resembles an iliac graft, with thick internal cancellous bone and a thin external cortical layer. This leads to an ideal graft, with a high regenerative capacity comparable to iliac bone and a stable regenerated volume with optimum osseointegration potential close to that of mandibular block grafts.

Interpositional grafts have been successfully established in restoring vertical bone height . However much less evidence is present on its use for horizontal augmentation. It is the purpose of this study to assess the efficacy of autogenous onlay corticocancellous block grafts for anterior maxillary horizontal ridge augmentation as compared to onlay block grafts.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with missing upper anterior tooth / teeth with horizontal ridge dimension range from 2 to 5 mm (measured 2mm below alveolar crest).
2. Adequate vertical height.
3. Having good oral hygiene.
4. being healthy, with no systemic diseases that might contraindicate receiving a dental implant
5. Patients were able to comply with the follow-up and maintenance program

Exclusion Criteria:

1. Presence of local infection or lesions at site of interest.
2. Dental history of bruxism, or other parafunctional habits.
3. Uncooperative patients.
4. Current chemotherapy or radiotherapy.
5. Patients with aggressive periodontal disease
Use of a Smartphone APP for the Management of Postoperative Home Recovery

To calculate the incidence rates of postoperative adverse events (moderate and severe) and rehospitalization in patients undergoing thoracic surgery followed in follow-up using a smartphone application.

This is an observational, exploratory, cohort, retrospective study. For this study, data acquired on patients who participated in the trial period of the app will be retrospectively analyzed. Our Operating Unit used the care4today app on a trial basis during the period between March 1 and October 31, 2023, focusing on monitoring the first 30 days after discharge. The app was offered to patients scheduled for thoracic surgery involving access to the pleura. After a few setup questions, the app was activated upon discharge. For the first 15 days it sent daily questions via notification regarding general health status, postoperative pain, respiratory capacity, and resumption of activities. From day 15 to day 30 after discharge, questions were asked every 4 days. All relevant responses were forwarded via e-mail to the clinician in the form of an orange or red alert in relation to lesser or greater severity.

Patients were treated according to clinical practice in accordance with the clinician's judgment and the information in the Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. Informed consent will be collected during follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Patients undergoing thoracic surgery
* Patients who used the care4today app
* Obtaining informed consent to participate in the study

Exclusion Criteria:

* nothing
Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19

For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or povidone-iodine or nothing (control group) as well as spray the same solution in their nose four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7 days and viral loads will be measured.

COVID-19 has emerged as a worldwide pandemic and there is a strong need for identification of any measures that can be used to treat this illness or reduce its transmission from person to person. Povidone-iodine has been shown to have virucidal properties against multiple viruses including against the virus that causes SARS which is very similar in makeup to the virus causing COVID-19.

The investigators hypothesize that 4x daily use of oral gargles and nasal rinses using a povidone iodine solution will help to reduce the viral load in the nasopharynx and oropharynx in patients who are COVID-19+. If this hypothesis is shown to be true this could potentially have an impact on time to recovery of clinical symptoms as well as reduce shedding of the virus by infected patients. A time course of 7 days was chosen in order to recognize a trend in the viral load over time for patients receiving each of the interventions. Chlorhexidine gluconate and saline rinses were chosen as additional treatment arms as these are frequently used for oral and nasal hygiene and their role in affecting viral load is currently unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Positive test for COVID-19
2. Age 18-79 years
3. Willing and able to perform oral gargles and nasal rinses four times daily

Exclusion Criteria

1. Requiring mechanical ventilation
2. Unable or unwilling to perform oral gargles and nasal rinses four times daily
3. History of chronic upper respiratory tract disease
4. Known iodine allergy
5. History of thyroid disease