cyrilzakka/clinical-trials huggingface dataset:
Artemether-Lumefantrine Clinical Effectiveness Study

In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national first-line drug for uncomplicated malaria. The principal purpose of this study is to measure the absolute effectiveness of AL when used under real-life clinical conditions, as compared to optimized in-vivo trial conditions. This question was raised by the National Department of Health in preparation for the country-wide roll-out of AL.

The study is designed as a randomized controlled trial comparing two study arms. Patients in the "effectiveness arm" receive the first dose of AL under full supervision in the clinic; the following doses will be taken at home, as in real-life clinical practice and according to the new national treatment guidelines. Patients in the "efficacy arm" will receive all doses of AL as directly observed treatment in the clinic in order to establish the efficacy of the drug when used under ideal conditions.

The study will enroll outpatients aged 6 months to 10 years with a history of fever and a positive rapid test for malaria. Patients meeting all enrollment criteria and providing full written informed consent by a parent/caretaker will be randomized into either of the two study arms. Patients in both arms will be followed up actively for 42 days. Patients in the efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in the effectiveness arm on days 0, 3, 7, 14, 28 and 42.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 10 years (+/- 1 month for children without known date of birth)
* Permanent resident in the study area
* Not enrolled in another study at the same time
* No known history of hypersensitivity reactions to artemether or lumefantrine
* History of fever in the previous 72 hours (approximate)
* Rapid diagnostic test (RDT) positive for any species of Plasmodium

Exclusion Criteria:

* General danger signs: inability to drink or breastfeed, vomiting everything, recent history of convulsions, lethargy or unconsciousness, inability to sit or stand up
* Signs of severe malaria (impaired consciousness, respiratory distress, circulatory collapse, abnormal bleeding, jaundice, or as determined by clinician)
* Severe malnutrition: defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet; or middle upper arm circumference under 12 cm
* Clinically significant concomitant disease requiring admission
* Contraindications mentioned in the national treatment guidelines
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System

Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically ventilated patients and within the framework of Respiratory Intensive Care Units. The AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system that includes a number of unique characteristics. This study was designed to test the frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients;
* Patient was connected to AnapnoGuard system up to six hours from intubation;
* Age - above 18.

Exclusion Criteria:

* Pneumonia;
* Aspiration Pneumonia;
* Chronic or Severe Pneumonia;
* Chronic Obstructive Pulmonary Disease (COPD) requiring permanent home-based antibiotic treatment;
* Interstitial Lung Disease (ILD);
* Post Lung Transplant State;
* Immunosuppression.
* Patients ventilated in prone position
* Patient who was ventilated 3 months prior to being enrolled in the study
* Pregnant women
Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery

In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.


Eligibility Criteria:
Inclusion Criteria:

1. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center

1. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate
Epidemiology of Coronary Heart Disease in Blacks

To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction' study.

BACKGROUND:

Ample data now exist to dispel the prevailing clinical impression that coronary heart disease (CHD) occurs infrequently in United States Blacks. It is well known that CHD is the leading cause of death among United States Blacks. Among patients with acute myocardial infarction who often present with typical ischemic chest pain, it has been shown that Blacks present more often without chest pain when compared to whites and Hispanics. In addition, more than 25 percent of the myocardial infarction patients have unrecognized infarctions. Morbidity and mortality associated with angina pectoris, cardiovascular disease, and myocardial infarction occurs in United States Blacks at rates which are at least comparable to their white counterparts. Yet, there are limited epidemiological studies designed to identify the determinants of CHD in the Black population.

The patients were originally screened to participate in a multicenter clinical trial on 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction.' Only 28 patients out of 599 screened subjects were eligible for the SAVE study. The baseline data obtained from the 599 screened subjects comprised the database.

DESIGN NARRATIVE:

Data analysis was performed to: determine the prevalence of coronary heart disease in Blacks presenting with chest pain; identify the correlates of CHD in Blacks; determine the sensitivity and specificity of a Rose questionnaire angina in Blacks; determine the association between the Rose questionnaire angina and CHD manifestations in Blacks, and identify predictive and causal models of CHD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd

Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.

The study will evaluate a new twin source relatively compact CT scanner with advanced technology which is optimized for cardiovascular imaging. Eligible patients with a clinical indication will undergo coronary or cardiac CT scans using the new SpotLight CT from Arineta Ltd. Image quality and usefulness of the new system will then be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic patients with a clinical indication for cardiac CT
2. Patients with a clinical indication for CT
3. Estimated GFR \> 60 mL/min

Exclusion Criteria:

1. No clinical indication for CT scanning
2. Contra-indication for CT scanning or for IV contrast administration
3. Pregnancy
4. Inability to give an informed consent
Assessing the Impact of Elelyso on Bone Involvement Currently Treated With Other ERTs

The objective of this study is to assess Elelyso treatment on bone disease in Gaucher patients currently treated with other enzyme replacement therapy.

Experience from early access program (2009-2012) has suggested that some patients who have been stable on imiglucerase have shown poor scores of QCSI with Fat Fraction below the cut off point of 0.23 which is considered "bone at risk", and have demonstrated remarkable improvement upon switching to Elelyso, including particularly 2 patients who did not have any change in dose or any drug interruption prior to the switch.

These findings may be explained by the better glycan structure of imiglucerase (see Tekoah et al, 2013). The fact that in many patients prevention of bony complications is the main indication for ERT highlights the importance of this study, as all clinical trials of all ERTS heretofore did not include the bones as primary or secondary end-points but only as exploratory, and as such had only limited value,

Open-label study in patients with Gaucher disease currently treated with commercial ERTs. Eligible patients will receive intravenous (IV) infusions of Elelyso every two weeks. The infusions will be administered at the selected medical center or in the home care setup. The dose of Elelyso will be the same dose of the other ERTs . Bone parameters QCSI and BMD will be assessed at baseline, 12 months and 24 months.

The intention is to open 3 more sites in Israel thereby making this IIR a multi center national trial

Eligibility Criteria:
Inclusion Criteria:

* GD patients, male and female, 18 years or older
* Currently treated with enzyme replacement therapy for 5 years and more, with a stable unchanged dose in the previous 6 months
* Imaging features of significant residual bone disease defined as QCSI under 0.3 bone at risk
* Able to provide written informed consent

Exclusion Criteria:

* Currently taking another experimental drug for any condition
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the requirements of the study.
* Past exposure to Elelyso
Assessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera

The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 80 years
* Suspected coronary disease and / or coronary syndrome patient ST-
* Patient who has been informed of the study and has given his informed consent
* Patient affiliated to a social security system.

Exclusion Criteria:

* Patient having no coronary disease at coronary angiography with FFR on the 3 main epicardial arteries (absence of ≥ 50% stenosis of at least one artery)
* Delay of Care grater than 30 days between the PET and SPECT imaging and the diagnostic coronary angiography
* Patient with a recent history of myocardial infarction and STEMI, unstable angina
* Patient with extra-cardiac disease whose prognosis can interfere with the treatment decision
* Pregnant or lactating women
* Patient allergic to contrast products during coronary angiography
* Patient with MDRD clearance les than 60 ml / min
* Patient Under guardianship, or unable to understand the purpose of the study
Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis

Exclusion Criteria:

* Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension,
* Have preexisting exertional dyspnea,
* Geographically inaccessible for follow-up,
* Decline to participate in the study.
Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a severe, progressive and potentially fatal disease that impairs the pulmonary circulation and leads to right ventricular failure. One of the world most prevalent etiologies of PAH is schistosomiasis-associated pulmonary arterial hypertension (Sch-PAH). New drugs have emerged to treat other forms of PAH, but their benefits cannot be automatically translated for Sch-PAH patients, since this etiology was not included in the pivotal PAH trials. One of the most promising therapies for the treatment of PAH to emerge in recent years is selexipag, an oral IP receptor agonist, which acts on the prostacyclin pathway. The present study aims to evaluate the efficacy, safety and tolerability of selexipague for the treatment of schistosomiasis-associated pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic Sch-PAH. Sch-PAH diagnosis necessarily include the three criteria below

  1. Invasive confirmation of PAH, according to the criteria defined in the Pulmonary Hypertension Sixth World Symposium: mean pulmonary artery pressure higher than 20 mmHg, at rest, and the presence of pulmonary vascular resistance (PVR) equal to or greater than 3 W, and a pulmonary capillary pressure considered normal (equal to or lower than 15 mmHg (1)).
  2. At least one epidemiological criteria for chronic schistosomiasis: patient from a highly prevalent region for schistosomiasis or previous history of parasitic treatment for schistosomiasis or the presence of Schistosoma mansoni eggs in the patient's feces
  3. Evidence of long-term hepatosplenic involvement by schistosomiasis, via compatible ultrasound findings (peri-portal fibrosis or enlarged left lobe) All patients will necessarily already be receiving at least one specific treatment for PAH, either with phosphodiesterase V inhibitor or with an endothelin receptor antagonist, with a stable dose for at least 12 weeks before inclusion in the study.

     Exclusion Criteria:
* Patient without clinical condition to perform the 6-minute walk test
* Patient with gastro-intestinal bleeding for over 12 weeks
GABA-B Receptor Function in Healthy Volunteers

There are several developing lines of evidence suggesting that brain receptors called GABA-B receptors play a significant role in addiction and its treatment. The investigators wish to examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of the investigators MRC programme of research in neurotransmitters in alcohol and opiate addiction (NOAA). In this present study the investigators will give 2 different single doses of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects GABA-B receptors in the central nervous system and is licensed for the treatment of spasticity in people with eg spinal injuries; the investigators are interested in its effects on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye movements, blood pressure and heart rate, motor co-ordination and subjective effects and also blood levels of the drug in the investigators volunteers before and at intervals after dosing. The investigators will use a double-blind randomised design to minimise expectation effects. The study will provide information on timing and magnitude of effects of baclofen on brain function in healthy subjects so that the investigators can optimise selection and timing of functional measures in future studies of addicts.

After informed consent and screening participants will attend for 3 study days. On each of these there will be a set of baseline measurements including EEG, saccadic eye movements, vital signs, motor co-ordination task, subjective visual analogue ratings and questionnaires and blood sample. After dosing these measurements will be repeated at intervals during the day up to 6 hours after dosing. Participants will be allowed home after a health check.

Eligibility Criteria:
Inclusion Criteria:

* Currently healthy
* Non-smoker
* Willing to comply with protocol
* Excellent understanding of English (for questionnaires)
* Alcohol consumption between 1 and 28 units/week

Exclusion Criteria:

* Current or past history of psychiatric or substance use disorder
Flipped Learning in PPH Education: Impact on Midwifery Students' Knowledge, Skills, Self-Efficacy, and Satisfaction

Maternal death refers to a woman's death due to direct or indirect causes during pregnancy, childbirth, or within 42 days postpartum. Postpartum hemorrhage (PPH) is the leading cause of maternal mortality globally and in our country. Rapid and effective management of PPH is crucial in reducing maternal deaths. WHO, UNFPA, and UNICEF emphasize the critical role of midwives in PPH management, highlighting the importance of enhancing their knowledge and skills during pre-graduate education.

Traditional education models are often insufficient for fostering permanent learning, especially in acquiring psychomotor skills like PPH management. In traditional learning, classroom instruction follows a teacher-centered approach, covering only the first two levels of Bloom's taxonomy-knowledge and comprehension-while higher-order cognitive skills such as application, analysis, synthesis, and evaluation are left to individual effort. However, effective and lasting learning requires an active learning environment where students engage more deeply with the material.

The flipped learning model addresses these challenges by allowing students to access foundational knowledge outside the classroom and dedicate class time to higher-order skills like discussion, application, and problem-solving. This model enhances learning through technology and interactive face-to-face activities, fostering professional competence in health education. While the flipped learning model is widely used in health education, most studies focus on theoretical knowledge, with limited research on psychomotor skill acquisition.

To our knowledge, this study is the first to evaluate the effectiveness of flipped learning in midwifery education for both theoretical and psychomotor skill development. The findings are expected to contribute to advancements in midwifery education and healthcare services.


Eligibility Criteria:
Inclusion Criteria:

* Being a 3rd year student in the Midwifery Department of Gülhane Health Sciences Faculty
* Having successfully completed the normal birth course
* Agreeing to participate in the study

Exclusion Criteria:

* Students who were on sick leave or on sick leave during the study period
* Those who did not take the normal birth course or failed
* Students who were absent from at least one session of the training program
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

* Positive titres for anti hepatitis B antibodies.
* Any vaccination against hepatitis B in the past.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.
Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer

To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histological Diagnosis of stage IV colorectal cancer
* Hepatic metastasis and/or peritoneal potentially resecable
* Patient affiliated with a mode of the social security or recipient of such a mode
* Information of the patient or his legal representative and collection of his assent

Exclusion Criteria:

* None metastatic colorectal cancer
* Cancer of appendicular origin
* Patients deprived of liberty or unable to give his assent
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ years of age.
* Moderate to severe rheumatoid arthritis of ≥ 6 months duration.
* Receiving treatment on an outpatient basis.
* Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.
* On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
* Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
* Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis.
* History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.

Other inclusion and exclusion criteria applied to the study.