cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss

The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).

The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.

Aim: To investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss.

Primary objective: To test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss.

Secondary objectives: To test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. The investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life.

Women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. The participants will be randomized to two groups. First group will receive oral mifepristone (600 mg) and the second group will not. The remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost.

Three weeks after medical treatment, primary and secondary outcomes will be assessed. In case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed.

220 women will be randomized in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management
* Age 18 years and older
* Intra-uterine pregnancy
* Hemodynamically stable patient
* No signs of infection
* No signs of incomplete miscarriage
* Willing and able to give informed consent

Exclusion Criteria:

* Women opting for alternative methods of miscarriage management (expectant or surgical)
* Diagnosis of incomplete miscarriage
* Life threatening bleeding
* Hemodynamically unstable patient
* Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria
* Previous participation in this trial
* Unable to give informed consent
Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery

This pilot randomized-controlled study will determine the feasibility of large study comparing individualized versus standard blood pressure (BP) management in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB). Our hypothesis is that maintaining higher BP levels based on preoperative measurements will reduce the incidence of major complications (composite outcome).

Adequate hemodynamic control is a cornerstone in management in patients undergoing different types of surgery. Among all perioperative risk factors, the association between perioperative hypotension and adverse clinical outcomes in noncardiac and cardiac surgery patients is well defined.

Numerous factors are responsible for development of perioperative hypotension. They include but not limited to perioperative use of renin-angiotensin-aldosterone system and calcium channel blockers, hypovolemia, hemodilution, bleeding and inflammatory response syndrome.

To date, several evidence has been accumulated indicating that intraoperational hypertension can be hazardous.

It was shown that even short durations (1 to 5 min) of an intraoperative mean arterial pressure \< 55 mmHg were associated with myocardial injuries and acute kidney injury (AKI).

Results of recent large retrospective cohort study conducted in adult patients who underwent cardiac surgery requiring CPB showed that postoperative stroke was strongly associated with sustained mean arterial pressure of less than 64 mmHg during cardiopulmonary bypass.

In patients undergoing CABG the overall incidence of combined cardiac and neurologic complications was significantly lower in the group where MAP during CPB was relatively high (80-110 mmHg) than in the low pressure group (MAP 50-60 mmHg) (p = 0.026). For each of the individual outcomes the trend favored the high pressure group.

Therefore, MAP may be an important intraoperative therapeutic hemodynamic target to reduce the incidence of complications in patients undergoing CPB.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Signed informed consent
* Elective cardiac surgery under CPB (CABG or valve surgery)

Exclusion Criteria:

* Unstable Coronary Artery Disease: Recent (\< 6 weeks) myocardial infarction, unstable angina, severe (\> 70%) left main coronary artery stenosis
* Uncontrolled hypertension preoperatively (SBP \> 160 mm Hg)
* Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or intraaortic balloon pumping, preoperative severe acute renal failure (anuria or oliguria \<10ml/hr)
* Planned surgery on aorta
* Emergency surgery
* Pregnancy
* Current enrollment into another randomized controlled trial (in the last 30 days)
* Previous enrollment and randomization into current study
* Glomerular filtration rate ≤59 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures

EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
* Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
* Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024

Exclusion Criteria:

* Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
* Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia

Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.

The clinical diagnosis of children with leukemia may be due to the influence of leukemia disease on the immune cells of the children and the damage to the immune system due to immunosuppressive therapy in children. Therefore, the risk of contracting hepatitis B virus is relatively high, and some children are In the treatment of immunosuppressive chemotherapy (later), the reactivation of occult HBV infection has an impact on the normal course of leukemia treatment. However, this is not a clinically relevant diagnosis and treatment measure. It is necessary to avoid unnecessary conflicts between clinical doctors and patients as much as possible.

Eligibility Criteria:
Inclusion Criteria:

The clinical diagnosis of children with leukemia received systemic chemotherapy.

Exclusion Criteria:

Children with non-leukemia and children without appropriate treatment.
Living Well After Breast Surgery

Decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. Patient decision aids can improve decision quality for a variety of health conditions. This pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.

Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer.

Participants will complete up to three surveys; a baseline survey before viewing the decision aid or website, a second survey immediately after viewing the decision aid or website, and a third survey six months after surgery. Tablets will be made available to participants at the study site through which they can complete the surveys and view the decision aid or website. Participants will have the options of viewing the decision aid or website outside of the study site, and completing the three surveys electronically or on paper.

The baseline survey and second survey will each take approximately 45 minutes for participants to complete. The third survey will take approximately 30 minutes for participants to complete.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Adult (18 years or older)
* New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or Ductal Carcinoma in Situ (DCIS)
* Not yet had mastectomy
* Considering or planning to have mastectomy
* Able to read and speak English
* Competent to make health care decisions

Exclusion Criteria:

* Male
* Age less than 18 years
* Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma
* Already had mastectomy for this diagnosis
* Planning to have breast conservation therapy
* Not being treated by a Texas Oncology surgeon or oncologist
* Not able to read and speak English
* Not competent to make health care decisions
Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

Rhinosinusitis is a common clinical problem with significant morbidity which alters patients' quality of life that has its effect on 1 out of 7 adults. It has been found that rhinosinusitis accounts for almost 26 million clinics and emergency visits per year in United states .Nasal irrigation is standard management used to treat a variety of sinonasal diseases. Furthermore, nasal irrigation decreases the need of usage other medications in rhinosinusitis .Hence, it is considered safe, inexpensive, and easy to use with no evidence of major adverse effects .Up to our knowledge, there is no clear guideline in which type (isotonic saline vs hypertonic saline) and frequency (times per day) of nasal irrigation are superior and better.

Nasal irrigation is one of the main treatment of sinonasal diseases. The mechanism of action of nasal irrigation has many physiological aspects such as removing of excess mucus which is a potential medium for bacterial growth and infection, cleaning of antigens and biofilm to decrease inflammatory process, increase mucocilliary function and removing curst and debris from post-surgery to enhance wound healing and mucosalization Hypertonic saline is defined as a solution with more than 0.9% weight per volume of sodium chloride while isotonic saline is defined as a solution that equals to 0.9% weight per volume of sodium chloride. There are controversial studies in the literature on which saline is superior on the other, some prefer hypertonic saline over isotonic saline because it can move water outside the cells, decrease edema of mucosa, increase hydration of sol layer and decrease muco-adhesiveness and improve mucociliary clearance while others found both solution had same efficacy, improved nasal stuffiness and nasal obstruction but patients prefer isotonic saline because it is well tolerated and less burning sensation. Frequency of nasal irrigation per day is poorly studied in the literature with no known recommended times per day. Our aim is to find which type of saline and number of irrigation per day are better and statistically significant .

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 years of either gender
* Acute and chronic rhinosinusitis

Exclusion Criteria:

* History of nasal or sinus surgery
* Age less than 18 years of either gender
* diagnosis other than rhinosinusitis
Efficacy of Kangliuwan for Recurrent Grade IV Glioma

A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.


Eligibility Criteria:
Inclusion Criteria:

1. The patient signed "informed consent" voluntarily;
2. The age of patient is between 18 and 80 years;
3. KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;

Exclusion Criteria:

1. The patient did not sign "informed consent" or signed unvoluntarily.
2. Non-glioma patients
3. Active infection
4. Human immunodeficiency virus (HIV) positive
5. Hepatitis C or hepatitis B infective
6. Pregnancy or breast-feeding women
7. Patients did not agree to use effective contraception during treatment and the following 3 months.
8. Patients also participated in other clinical studies.
9. The subjects researchers believe are not suitable for participation or completion of the study.
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
* Other criteria also apply

Exclusion Criteria:

* Other major illnesses
* Past history of certain other disorders
* Certain prohibited medications
OrthoEvidence Trial Assessing Japanese Knowledge Updates

The purpose of this randomized controlled trial is to clarify whether providing translated evidence summary (Advanced Clinical Evidence (ACE) reports from OrthoEvidence) will increase the access to the summary compared to providing the original version of evidence summary among Japanese orthopaedic surgeons

The investigators will conduct the survey regarding baseline characteristics, barriers and familiality to evidence-based medicine by online. After the survey, the participants will be randomly assigned to receive either the original version of ACE reports or Japanese version of ACE reports. The pdf of each ACE report will be provided to the participants through an email link. Twenty reports will be sent over 4 weeks period. After that, the investigators will conduct another survey regarding the reports.

Eligibility Criteria:
Inclusion Criteria:

1. Member of Japanese Society for Fracture Repair (JSFR)
2. Spend at least 20% of their time in clinical practice
3. Non-native speaker of English
4. Has regular access to internet
5. Prefer to read Japanese-translated material, if there are both translated and English version of the same material.

Exclusion Criteria:

We will exclude surgeons who cannot provide informed consent.
Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses

The aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses.

This study will be conducted using a randomized, crossover design with three dietary phases: 1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large lipid droplet size) and 3) non-emulsified oil and water. All treatments will be consumed together with bread. All participants will be randomly allocated to the three test meals. Fifteen to twenty participants aged between 21 and 50 years will be recruited from the general public in Singapore.

During the testing sessions, participants' glycemic, insulinemic, lipidemic responses and gastric emptying to the test meals will be measured. Gastric antral distention ultrasound measurement is an indirect measure of gastric emptying rate. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. Each testing session will take approximately four hours in duration and the testing sessions will take place at least five days apart.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese male subjects aged between 21 and 50 years
* Body mass index between 20.0 to 24.9 kg/m2
* Normal blood pressure (\<140/90 mmHg)
* Fasting blood glucose \<6.0 mmol/L

Exclusion Criteria:

* People with major chronic disease such as heart disease, cancer or diabetes mellitus
* People with family history of diabetes or familial cholesterolaemic
* People with history of liver or renal problems
* People who have intolerances or allergies to test products
* Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
* People with a major medical or surgical event requiring hospitalization within the preceding three months
* Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion related oxidative stress which could further lead to the development of organ failure in critically ill patients. Perioperative levels of macrophage migration inhibitory factor (MIF) and other inflammatory mediators could be involved in adverse outcomes in cardiac surgery.

The trace element selenium (Se) serves as an essential co-factor for the antioxidant enzymes Thioredoxin - reductase (TRR) and many other antioxidant enzymes, which protect tissues from oxidative stress. In septic patients it has previously been shown that thioredoxin, a TRR regulated Redox Enzyme, has the ability to suppress the synthesis of MIF.

Aim of the present study is therefore to investigate the relation between perioperative selenium decrease and the reduction of TRR activity with a possible release of MIF during the inflammatory response after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years of age
* open heart surgery and use of heart-lung-device
* informed consent has been obtained

Exclusion Criteria:

* under 18 years of age
* emergency cases
* informed consent cannot be obtained
* pregnancy or patient is breast-feeding
Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin is usually used to monitor the iron overload. In this study MDS patients will have a transient elastography performed which measures the liver's stiffness. The purpose is to investigate whether liver stiffness measurements are coherent to ferritin levels.

Transient elastography is noninvasive and has no side effects. No liver biopsy will be performed due to serious side-effects and risks in this patientgroup.

The results of the transient elastography will be compared to the patient's ferritin levels and the numbers of months the patients have had MDS to find out if there is a correlation. Furthermore we will compare the liver stiffness measurements in the patients with higher ferritin levels to those who have lower ferritin levels. We will also compare the liver stiffness measurements in patients who are red blood cell transfusion dependent compared to those who are red blood cell transfusion independent. We will also compare liver stiffness measurements in the patients with a high alanine aminotransferase (ALAT) compared to those with normal ALAT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a bone marrow describing myelodysplasia

Among these:

* Patients with myelodysplastic syndrome (MDS)
* Patients with acute myeloid leukemia (AML) transformed from MDS
* Patients with chronic myelomonocytic leukemia (CMML) with dysplasia
* Patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable

Exclusion Criteria:

Body mass index (BMI) of 30 or higher than 30

- History with other known liver diseases

Among these:

* Patients with chronic viral hepatitis C infection
* Patients with chronic viral hepatitis B infection
* Patients with alcoholic liver cirrhosis
Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age above 21 years and below 60 years
* Voluntarily signing of the informed consent form
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
* Subjects willing and able to abstain from partaking in any procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy
* Breastfeeding
* Injured or otherwise impaired muscles
* Scars, open lesions and wounds at the treatment area
* Basedow's disease
* Previous liposuction in the treatment area in the last six months
* Abdominal wall diastasis
* Unstable weight within the last 6 months (change in weight ± 3%)
* Previous body contouring treatments in the abdomen area in the last three months
* Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
* Any disease or condition that may compromise the histologic observation at the pathologist discretion