cyrilzakka/clinical-trials huggingface dataset:
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain

The purpose of this study is to evaluate the safety of a fixed combination of acetaminophen/naproxen sodium when administered as multiple doses over a period of up to 10 days in adolescents 12 to below 17 years of age with post-procedure orthodontic pain.


Eligibility Criteria:
Inclusion Criteria:

* Weigh 72 pounds or greater and have a body mass index (BMI)-for-age between the 5th and 95th percentile (inclusive) at Screening
* Have undergone an orthodontic procedure within 4 hours prior to baseline (enrollment) visit
* Females of childbearing potential and males agree to the contraceptive requirements of study

Exclusion Criteria:

* Are female and are pregnant, breastfeeding, or trying to become pregnant or male with a pregnant partner or a partner currently trying to become pregnant
* Have a positive urine drug test on screening or enrollment
* Are not able to swallow whole tablets or capsules
* Arrive at the site on the day of enrollment with motion sickness and/or have a history of frequent motion sickness (car sickness) in the past year, which in the judgement of the investigator is likely to confound assessment of adverse events
* Routinely use oral analgesics greater than or equal to (\>=) 5 times per week
* Have a known allergy or hypersensitivity to naproxen (or other nonsteroidal anti-inflammatory drugs including aspirin) or acetaminophen or have asthma
* Have presence or a history of major medical condition that in the Investigator's opinion may jeopardize the participant's safety or wellbeing or the integrity of the study
* Have a history of chronic use of tranquilizers, alcohol, tobacco/vaping, or substance abuse, as judged by the Investigator site staff, in the last year
* Have a history of endoscopically documented peptic ulcer disease or bleeding disorder in the last two years
* Have a diagnosis of gastroesophageal reflux disorder, or experienced frequent heartburn in the past year
Comparison of Web- Versus Classroom-based Basic Ultrasound and Extended Focused Assessment With Sonography for Trauma (EFAST) Training in Two European Hospitals

Study Objective: Training physicians in new skills via classroom-based teaching has inherent costs and time constraints. We sought to evaluate whether web-based didactics result in similar knowledge improvement and retention of basic ultrasound principles and the EFAST (Extended Focused Assessment with Sonography for Trauma) compared with the traditional method.

Methods: Physicians from two German emergency departments were randomized into a classroom group with traditional lectures and a web group that watched narrated lectures online. All participants completed a pre- and post-test, and a second post-test eight weeks later. Both groups underwent hands-on training after the first post-test. A control group completed the two initial tests without didactic intervention.


Eligibility Criteria:
Inclusion Criteria:

* Physicians currently practicing in a German emergency department
* Age ≥ 18 years

Exclusion Criteria:

* Inability to participate in all aspects of the study prior to study begin
* Control group: Subjects who did not complete the pre-test
Multidisciplinary Team in Management of Placenta Accreta

comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only

cohort of 1000 patients of placenta accreta are followed regarding the incidence of urological injury in the cases with assistance from the urological staff members

Eligibility Criteria:
Inclusion Criteria:

* pregnant 38 weeks
* placenta accreta

Exclusion Criteria:

* medical disorders complicating pregnancy
The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual

This study argues that providing evidence-based occupational therapy patient education is vital in order to optimize rehabilitation outcomes. The planned trial aims to evaluate the SADL-eM intervention for people with SCI compared with standard treatment.

This is a parallel randomized clinical trial with two study arms, intervention and control. Ninety patients treated in three inpatient rehabilitation settings will be randomly allocated to two study groups. Both groups will receive standard care. The intervention group will also receive a copy of the SADL-eM from their treating occupational therapist during an individual session. Assessment on admission (baseline measure) and after six weeks of admission will use the SCIM-SR as the primary outcome measure. Secondary outcomes include the SCIM-III, Private Religiousness Practices Scale, Organizational Religiousness Short-Form, additional domains of ADL covered by the educational manual, and adherence to the intervention. The effect will be determined using repeated-measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SCI diagnosis by computed tomography or magnetic resonance report.
* ASIA: A, B, and C
* Age between 18 and 65 years old.
* Stable medical condition.
* Time elapsed after SCI is not more than 6 months.
* Minimum time of stay in the inpatient rehabilitation unit is six weeks.
* Active involvement in the rehabilitation program.
* Sufficient comprehension (read/write) of the Arabic language.

Exclusion Criteria:

* Unconfirmed diagnosis.
* Patients who have communication and/or cognitive disorders such as global aphasia and memory deficit.
* Patients with a disturbed level of awareness such as coma or lethargy.
* Time elapsed since SCI is more than 6 months.
* ASIA: D and E
* Unstable medical condition.
* Patients who have other cause(s) of disability in addition to SCI such as stroke or amputation.
* Age less than 18 or more than 65 years old.
* Time of stay in the inpatient rehabilitation unit is less than six weeks.
* Inactive involvement in the rehabilitation program.
* Patients with progressive disease or a psychiatric condition that would interfere with active participation in the rehabilitation programs.
* Patients with cardiovascular contraindications.
* Persons who become walking ambulatory during the inpatient period.
* Persons with complete tetraplegia C4 or above.
* Persons on a mechanical ventilator.
Individualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study

The purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer patients receiving emetogenic chemotherapy regimens such as anthracycline with cyclophosphamide-based chemotherapy and platinum-based chemotherapy.

To help clinicians prescribe antiemetic medications in a more patient-centered, evidence-based and cost-effective manner, we've developed the world's first validated risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of this, it is now possible to perform a trial of personalized precision antiemetic therapy for breast cancer patients.

Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains among the most feared and expected side effects of chemotherapy for breast cancer. Inadequately controlled CINV can significantly reduce a patient's quality of life, impair functional activity, lead to chemotherapy dose delays and reductions, and even discontinuation of treatment. The merit of current antiemetic medications is based on their ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is the major issue for breast cancer patients.

With olanzapine demonstrating significant promise in preventing acute and delayed nausea, the investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for CINV. For patients at low personal risk for CINV the investigators will also evaluate guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine (5 mg).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed invasive breast cancer (stage I-III) scheduled to receive neo/adjuvant anthracycline/cyclophosphamide or platinum-based chemotherapy
* ≥18 years
* Able to provide consent and complete all study-related diaries and questionnaires.

Exclusion Criteria:

* Received previous chemotherapy
* Symptoms of nausea or vomiting at baseline
* On chronic antiemetic therapy (e.g. metoclopramide); on daily long term oral steroids prior to chemotherapy
* Allergic or having a medical condition that makes the administration of olanzapine, aprepitant, 5-HT3 antagonists or dexamethasone contraindicated
* Uncontrolled diabetes
* Known/documented medical/psychiatric illness that would interfere with patients' ability to complete the diary and study-related questionnaires.
Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery

Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches have been proposed for treatment of chronic sternal wounds in these patients. however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia, atherosclerosis and malnutrition have main role against wound repairing. In this study investigators aimed to treatment of patients with open heart surgery and need to strict monitoring of sternal wound repair by Platelet Rich Fibrin.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by segment elevation (ST) changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
* The patient is scheduled to undergo coronary artery bypass surgery.
* The patient does not possess any contraindication for cardiovascular magnetic resonance (CMR).
* The patient is capable of giving informed consent.
* The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.

Exclusion Criteria:

* The patient is over the age of 65 years.
* The patient has previous myocardial infarction (MI) (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other left ventricular (LV) territory.
* The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
* The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
* The patient has undergone previous cardiac surgery.
* The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
* The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
* The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
Safety and Efficacy Evaluation of the Mosaic Ultra Device

Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, Male or Female
* Age 18 - 60 years old
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
* Participants who are willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* OPTIONAL - Participants who are willing to undergo biopsies.

Exclusion Criteria:

* Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure
* A study participant must not be pregnant or have been pregnant in the last 3 months
* A recent history of smoking (6 months)
* Presence of an active skin disease or condition that may affect wound healing (ie. diabetes myelitis; connective tissue disease; radiation therapy; or chemotherapy)
* Seizure disorder caused by bright light
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Cancer, malignant disease, skin pathology, condition, or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during, or after treatments
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E, or anti-inflammatories within 2 weeks prior to treatment
* Intolerance or allergy to medications that could be prescribed before or after the procedure (eg, antibiotics, anesthesia)
* A history of keloids
* A history or evidence of poor wound healing
* A history of coagulative disorder or current use of anticoagulant drugs within 2 weeks of study participation
* Use of steroids within 2 weeks of study treatments
* Patients with implanted pacemaker or defibrillator, or metal pins, or prosthetic joints within 4 cm of treatment area
* History of psychoneurosis and/or a history of alcohol or drug abuse
Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.


Eligibility Criteria:
Inclusion criteria:

Main Inclusion Criteria: Male and female patients \>=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure \>=95 and \<=119 mmHg Main

Exclusion criteria:

Exclusion Criteria:

1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).

The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a stable upright position during 20 min. This is an addendum to the previous study with record number clinical trials.gov NCT02124863


Eligibility Criteria:
Inclusion Criteria:

* Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR)

Exclusion Criteria:

* : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight \>50 kg (110 lbs.)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (e.g., gastrectomy).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.
Response of NAFLD Patients to Mediterranean Diet

The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile were also investigated.

Diet is a modifiable key factor targeted in prevention and management of non-alcoholic fatty liver disease (NAFLD). The aim of the study is to investigate the effect of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile are investigated. In this non-randomised, open-label study, 44 untreated NAFLD patients with non significant fibrosis receive nutritional counsel to increase adherence to MedDiet. Adherence to MedDiet is estimated with MedDietScore. Furthermore, genotyping of STAT3 rs2293152 and GCKR rs1260326 single nucleotide polymorphisms takes place.

Eligibility Criteria:
Inclusion Criteria:

* men and women \>18y of age, no change in body weight (BW) for the last 6 months prior to the trial and body mass index (BMI) \>25 kg/m2.

Exclusion Criteria:

* the presence of chronic viral hepatitis, the presence of congenital or acquired liver disease, the history of prior exposure to hepatotoxic drugs, the evidence of hepatic cirrhosis, ultrasonography values less than 1Hz, bariatric surgery, daily consumption of ethanol more than 20g for women and more than 30g for men for over 6 months during the last 5 years, any medication effective on fatty liver disease introduced \<6 months prior to or during the trial, the co-presence of a life-threatening disease, psychiatric disorders impairing the patient's ability to provide written informed consent, age\>65 years, pregnant or lactating women, subjects supplemented with omega-3 polyunsaturated fatty acids, probiotics/synbiotics, antioxidant vitamins and/or phytochemicals, any planned, structured and repetitive physical activity. Patients with any medication change during the trial were excluded from analysis.
Educational Support Interventions for Children in Care

A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13).

A Randomized controlled study of two different educational support interventions developed for children in foster care (age 6-13). One intervention is school-based and involves a team of professionals at the child's school, and the other is a home-based tutoring intervention provided by the foster parents. The participants in the study are assigned to three groups (the two intervention groups and control group). Based on power calculation we aim to recruit approximately 180-200 foster children, their foster parents and public schools to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* age 6-13
* fostercare placement
* placement in a participating municipality

Exclusion Criteria:

* persuasive developmental disorders
* special education students
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4

This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.

In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. Patients of this group will not receive intraoperative intra-abdominal chemotherapy. After performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

Eligibility Criteria:
Inclusion Criteria:

1. Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual:
2. Histologically verified adenocarcinoma of the colon.
3. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. The presence of synchronous or metachronous malignant tumors.
3. Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs.
4. Neoadjuvant chemotherapy.
5. Suspected Lynch syndrome.
Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia

Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children under 5 years. This rate was 2% in 2007.

Some studies have shown that supplementing with vitamin D reduces disease of the respiratory tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell lines. Studies about the role of vitamin D supplementation in pneumonia in children are inadequate to conclude about its role.

The aim of this study is to determine the efficacy of vitamin D supplementation in Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of hospitalized patients with community-acquired pneumonia.


Eligibility Criteria:
Inclusion criteria

* Aged between 2 months to 6 years
* Definite diagnosis of pneumonia

Exclusion criteria

* Immunocompromised patients
* Airway hypersensitivity or asthma
* allergies
* nasal polyps
* Using inhaled medications to one month prior to the study
* Receiving high doses of vitamin D
* Avoiding to complete informed consent form