cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study for an Oral Contraceptive Containing Folate

The purpose of this study is to determine whether the study drug is safe and effective

Acronym is used in result section: suspected/diagnosed (susp/diag)

Eligibility Criteria:
Inclusion Criteria:

- Healthy women between 18 and 40 requesting oral contraception

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study
Survival After First Myocardial Infarction in Patients With and Without Chronic Obstructive Pulmonary Disease

An estimated three million people are affected by chronic obstructive pulmonary disease (COPD) in the UK, giving it a prevalence of 1.5% of the population in 2007/08. COPD accounts for approximately 30,000 deaths each year in the UK and is an important co-morbidity in those dying from other smoking related diseases, most commonly ischaemic heart disease and lung cancer. The National COPD audit showed a very high level of co-morbidity, the association with cardiovascular disease being particularly strong with 51% of patients with cardiovascular disease having been admitted for COPD within the preceding 24 months. Patients with COPD are at increased risk of myocardial infarction compared to the general population. Although this increase in cardiovascular risk exists, it is not clear is whether survival after myocardial infarction is different in patients with and without COPD and what factors contribute to this survival difference. Differences in survival may arise due to differences in prescribing certain drugs such as beta-blockers, differences in prevalence of risk factors (e.g. current smoking status) or increased COPD events such as exacerbations which themselves are associated with increased mortality.

The investigators primary aim is to investigate whether survival after first myocardial infarction is shorter in patients with COPD than those without COPD and to establish reasons for these differences in survival.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Objectives:

1. To investigate survival differences after first myocardial infarction in patients with and without COPD.
2. To investigate if these survival differences exist due to a) differences in prevalence of risk factors (e.g. smoking) b) differences in management after myocardial infarction (e.g. uptake of cardiac rehabilitation, prescription of beta-blockers) and c) COPD related events (e.g. exacerbations).

Eligibility Criteria:
Inclusion Criteria:

* Patients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the MINAP dataset.
* Age over 18.

Exclusion Criteria:

* Patients will be excluded after experiencing their first MI.
* Patients will be excluded if they do not fulfil one of the inclusion criteria.
Is Masseteric Nerve Block Effective in Myofascial Pain

The aim of the present study was to compare the efficacy of three different treatment methods in the management of myofascial pain: masseteric nerve block (MN), trigger point injection(TrP) with local anesthetic (LA) and dry needling (DN).Study Design: 45 subjects aged 18-54 years were randomly assigned to the MN group (n= 15), LA group (n=15) and DN group (n=15).

The study sample consisted 45 patients with masseter muscle originated myofascial pain, were selected in accordance with the following criteria:

Patients were grouped according to the treatment they received: dry-needling (DN), TrP injections with local anesthetic (LA) and masseteric nerve block (MNB). Localization of the masseteric trigger points (MTPs) was based on clinician's sense and patients' expressions of pain. Local twitch response was not observable in all case. This procedure was completed by using digital palpation (1.5 Kg), and the clinical examiner's palpation was calibrated using a pressure algometer.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of myofascial pain.
* Presence of at least one trigger point in masseter muscle.

Exclusion Criteria:

* Generalized muscle disorders.
* Hypersensitivity to local anesthetics.
Clinical Investigation of Bleeding Reduction Efficacy on Toothpaste Containing 1.05% Chitosan

The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, aged 18-70, inclusive.
2. Availability for the duration of the study.
3. Ability to understand and willingness to read, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
4. Willingness to comply with all study procedures and clinical examination schedules.
5. Good general health (absence of any condition that, in the opinion of the study examiner, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements etc).
6. Presence of a minimum of 20 natural teeth (excluding third molars) with facial and lingual scoreable surfaces.
7. Have a mean Modified Gingival Index (Lobene) ≥ 2.5 at screening.
8. Subjects reporting bleeding while routine toothbrushing.

Exclusion Criteria:

1. Pregnant or lactating.
2. Use of tobacco products.
3. History of alcohol or drug abuse.
4. Medical condition (especially, heart or liver problems, bleeding disorders, blood dyscrasias) or any current usage of medication that the investigator considers may compromise the subject safety, as well as, the quality of the study results.
5. Medical condition which requires pre-medication prior to dental visits/procedures.
6. History of allergy to oral hygiene products.
7. Use of anti-inflammatory, immunosuppressive, antimicrobial or anticoagulant drugs or antibiotics in the 30 days prior to the start of the study and during the course of the study.
8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine).
9. Presence of orthodontic bands or removable partial denture(s).
10. Tumor (s) of the soft or hard tissues of the oral cavity.
11. Five or more carious lesions requiring immediate restorative treatment.
12. More than 2 periodontal pockets (\>4mm deep) with bleeding on probing.
13. Any gingival condition like hyperplasia or overgrowth, that would cause difficulty in clinical assessment.
14. Participation in any other clinical study with an oral care indication or test panel within 30 days prior to the start of the study.
15. Existing medical condition which prohibits the subject from not eating or drinking for periods of up to 2 hours.
Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

The primary objective of this study is to evaluate the effectiveness of the PLACES intervention on paid employment re-entry in unemployed and work-disabled cancer survivors, compared to CAU.

Secondary Objectives are:

* To evaluate the cost-effectiveness of the PLACES intervention aimed at unemployed or work-disabled cancer survivors.
* To evaluate the effectiveness of the PLACES intervention on time until paid employment, type of employment, change in working hours, quality of life, quality of working life, work ability, and self-efficacy regarding RTW, in unemployed or work-disabled cancer survivors.
* To evaluate the process of conducting the PLACES intervention in terms of recruitment, reach, dose delivered, dose received, fidelity and context.

Participants in the intervention group will receive the PLACES intervention with a maximum duration of 1 year, and participants in the control group will receive CAU.

Participants in the intervention group (n=82) will receive a tailored supported employment intervention, based on the principles of individual placement and support (IPS). This includes support in seeking, returning to and maintaining paid employment. Participants in the control group (n=82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after three (T1), six (T2) and 12 months (T3) follow-up. The primary outcome is obtainment of paid employment. Secondary outcomes are employment status, time until paid employment, change in working hours, importance of work, RTW expectations, work ability, quality of (working) life, and self-efficacy regarding RTW. Process evaluation and cost-effectiveness analysis will be performed.

It is expected that that a significantly higher proportion of participants in the intervention group will obtain paid employment at any point during 12-month follow-up compared to participants in the control group. Additionally, their health, financial situation and quality of life will be improved. If proven effective, the intention is to implement the intervention in usual rehabilitation care.

The study is funded by the Dutch Cancer Society (KWF) and in collaboration with the Netherlands comprehensive cancer organisation (IKNL) and the social security agency (SSA)

Eligibility Criteria:
In order to be eligible for participation, participants must meet all of the following criteria:

1. Of working age (18-65 years);
2. Diagnosed with cancer between 6 months and 10 years ago;
3. Unemployed and either partially or fully work-disabled
4. They have completed their primary treatment (except long-term treatment such as hormone therapy);
5. An approved reintegration trajectory at the SSA;
6. Seeking paid employment and motivated to initiate work promptly.

Cancer survivors who are unable to speak, read or understand the Dutch language and cancer survivors who got diagnosed with basal cell carcinoma will be excluded from participation.
Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery

The primary aim of this study is to observe the effects of two different methods of administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively in cardiovascular surgery, on patients' postoperative bleeding amounts. According to the hypothesis established in this study, it is anticipated that administering tranexamic acid as an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable blood level compared to the sole i.v. bolus application, thereby being more effective in influencing postoperative bleeding levels.

The study has been designed as a prospective observational research. The outcomes of two different tranexamic acid protocols applied during cardiovascular surgical procedures will be compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration.

The cases collected over a period of 14 months will be divided into two groups and compared in terms of intraoperative and postoperative bleeding levels, as well as their need for blood products.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have coronary artery disease requiring coronary artery bypass surgery with cardiopulmonary bypass and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study.
* Writen consent obtained

Exclusion Criteria:

* Patients operated on for reasons other than coronary artery bypass surgery
* Patients who operated on as emergencies
* Patients who have preoperative liver/renal dysfunction or a history of cerebrovascular events
* Patients under the age of 18
* Patients who have coagulation disorder
* Patients who have a history of allergies
* Pregnancy or lactation
* Disabled in spirit or law
Cognitive Behavioral Therapy and Real-time Self-management Intervention for SCD Via Mobile Applications

Patients with sickle cell disease (SCD) experience significant depressive symptoms that currently go unrecognized and under-treated. Further, depression in this patient population has the potential to contribute to high health care utilization and poor disease outcomes; however, there are currently no comparative effectiveness studies of evidenced-based mental health treatments for depression in SCD.

The primary objective of this study is to test the effectiveness of an online computerized cognitive behavioral therapy intervention to address psychological and behavioral needs of patients with sickle cell disease, namely depression and pain symptoms. The investigators will implement an existing computerized cognitive behavioral therapy (CCBT) program called "Beating the Blues" into routine clinical care at the University of Pittsburgh Medical Center (UPMC) Adult Sickle Cell Clinic to determine the effectiveness of this intervention in decreasing depression and pain versus treatment as usual. Patients with significant distress-depression and/or anxiety symptoms-will be randomized to either eight sessions of a CCBT program and weekly follow-up with a care manager or treatment as usual where the treating physician is notified of the patient's symptoms. The investigators will evaluate patient acceptability, implementation and practicality of the online mental health intervention through patient use of the site (frequency and duration of visits), qualitative interviews, and surveys. The investigators hypothesize: 1) the CCBT will be an acceptable mental health treatment for patients and easily integrated into routine clinical care; 2) patients in the treatment arm will show a greater decrease in depression/anxiety symptoms and average daily pain than patients in usual care.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age at baseline visit.
2. Documentation of a SCD diagnosis (HgbSS, HgbSC, SBeta +Thal; or SBeta oThal)
3. Receive routine care at the UPMC sickle cell clinic.
4. Scores indicative of clinically significant depression or anxiety on the stress/pain screener that is administered as part of routine SCD care to all patients. i.e. Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Generalized Anxiety Disorder scale (GAD-7) ≥ 8

Exclusion Criteria:

1. Presence of a condition or abnormality (e.g. significant neurocognitive dysfunction) that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program

Based on data on a cohort of 2,141 patients undergoing elective colonic cancer resection in an ERAS program, the incidence of postoperative thromboembolic events is estimated in patients no receiving prolonged thromboembolic prophylaxis.

The Copenhagen cOmplete Mesocolic Excision Study (COMES) database contains comprehensive data on preoperative, intraoperative, postoperative and tumor related variable on patients undergoing elective colonic cancer resection at four public university clinics providing all colorectal cancer treatment for the 1.8 million residents of the Capital Region of Denmark during the period 2014-2017.

None of these hospitals had implemented prolonged thromboembolic prophylaxis after discharge.

The medical records were reviewed with focusing on VTE prophylaxis, ongoing preoperative and postoperative anticoagulant treatment, the length of hospital stay (LOS), and readmission to ensure high data validity.

Eligibility Criteria:
Inclusion Criteria:

* elective macroradical resection for UICC Stage I-III colonic adenocarcinoma

Exclusion Criteria:

* concomitant rectum resection
* soly appendix carcinoma
* diagnosed with pulmonary embolism or deep venous thrombosis before primary discharge
* dying before discharge from the hospital or discharged at postoperative day 28 or later
* treatment with vitamin K antagonists, heparin or new oral anticoagulants before or after surgery
* VTE less than 3 months before the colon resection
Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery

This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.

This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :

1. in the bag IOL with limbal anterior vitrectomy
2. posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.

The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.

All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated cataract,
* unilateral or bilateral cataract,
* corneal diameter \>9.0mmHg

Exclusion Criteria:

* pre-existing glaucoma,
* uveitis,
* ocular comorbidity,
* microphthalmos,
* microcornea,
* parents not consenting to participate in study,
* traumatic cataract
Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease.


Eligibility Criteria:
Inclusion criteria

1. Adults aged ≥ 18 years with CKD stage III or IV.
2. Patients with anemia of CKD and a hemoglobin level \< 11.5 g/dL
3. Patients are receiving erythropoiesis-stimulating agent therapy.

Exclusion criteria

1. Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
2. Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.
3. Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.
4. Patients with current malignancies or a history of malignancy within the past 2 years.
5. Diagnosed with pure red cell aplasia.
6. Patients with severe gastrointestinal bleeding.
7. Pregnant or lactating females.
Primary Obstructive Megaureter Management in Eastern Interregional Area

Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and increased collagen 1 level. This malformation is accessible to antenatal screening from the second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed, this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney function.


Eligibility Criteria:
Inclusion Criteria:

* Minor patient (from 1 to 17 years old)
* Patient treated between January 2010 and December 2017 in one of the participating centers for an obstructive congenital mega-ureter
* Subject (and/or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion Criteria:

* Subject (and/or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research