cyrilzakka/clinical-trials huggingface dataset:
Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant, palonosetron and dexamethasone .In the other group,patients will accept the same dose of palonosetron and dexamethasone. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Histologically or cytologically confirmed nasopharyngeal carcinoma
3. Accept chemotherapy for the first time
4. Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV)
5. Written informed consent

Exclusion Criteria:

1. regnant or breast-feeding
2. Uncontrolled psychosis history
3. Inability or unwillingness to understand or cooperate with study procedures
4. Central nervous system tumors primary or secondary
5. Concurrent abdominal radiotherapy
6. History of uncontrolled diabetes mellitus
7. Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
9. Pre-existing nausea or vomiting
10. Inadequate hematological function and abnormal liver and renal function.
11. History of sensitivity to olanzapine
12. Concurrent application of quinolone antibiotic therapy
13. Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
15. Concurrent application of systemic corticosteroids
16. Active infection or gastrointestinal dysfunction
Online Video Training for Teachers to Improve Reading Skills in Children Using Augmentative and Alternative Communication

The aim of this study is to investigate , via a randomized control trial (RCT), the effectiveness of an online video training platform designed for teachers to support the improvement of basic reading skills of children with intellectual disabilities (ID) who require augmentative and alternative communication (AAC). This intervention will include 14 schools and 70 students with ID who require AAC age 6-14 years old. The research question is:

1) What is the difference between online video training and in-person training on improving word-level readig skills and phonological awareness?

The students will work with a reading material, Reading for All, that follow the strategies of Accessible Literacy Learning, developed by Janice Light and David McNaughton. Reading for All is based on the research of Janice Light and David McNaughton. The reading material are adapted for AAC-users and the students can answer with pointing or their AAC-systems. Teachers will implement the instructions at the students familiar place at school for three to five days, each week, for a year.

The reading material consist of tasks in sound blending, letter-sound correspondence, phoneme segmentation, sight words, shared reading and decoding. The teachers will use evidence based, systematic and explicit instructions and immediate and corrective feedback

Children with disabilities who require AAC may experiance challenges in various areas development, including communication skills, speech, language, cognitive and conceptual development, literacy, social participation, access to education, and overall quality of lifte. Acquiring reading skills may lead to higher levels of communication. Students who require AAC may be more dependent on others to provide and teach symbols to represent their language. Acquireing reading skills, may incrace the possibility to independently express themselves, and increace their access to for example text based communication devices.

There is a laci of evidence-based reading material adapted for students with ID who require AAC.

Primary outcomes will be assessed six times every two months over one year. The reading test are based on the reading material, which will be validated before the beginning of the trial.

Secondary outcome: four-time points (baseline, fourth, eighth, and twelfth month).

Eligibility Criteria:
Inclusion Criteria:

* ages 6-14 years,
* diagnosed with intellectual disability, confirmed by multidisciplinary assessments carried out by the Child rehabilitation service,
* not have a functional speech, i.e. require AAC to understand and make oneself understood,
* must use AAC as their primary form of communication,
* cannot follow ordinary curricula (LK20) but have their own education plan.

Exclusion Criteria:

* having a severe visual impairment and not being able to decode single words (e.g., severe hearing impairment).
Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach

Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy

The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US.

Treatment Choice of Patients:

Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients.

When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse

Exclusion Criteria:

* Other vaginal procedure to correct prolapse
Long-term Use of Mifepristone in the Treatment of Adenomyosis

The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups:

1. Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
2. Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.


Eligibility Criteria:
Inclusion criteria.

* Female, over 18 years old and not menopausal, agree to tripriline acetate and mifepristone treatment and informed consent
* Patients were diagnosed as adenomyosis by postoperative pathology, or those who did not undergo surgery but were diagnosed by auxiliary examination, such as ultrasonography and MRI.
* Dysmenorrhea with or Without Menorrhagia
* Requiring preservation of the uterus or fertility
* No other hormonal treatment for Adenomyosis was received in the three months prior to treatment
* Normal or non-clinically significant cervical cytology results (6 months before the screening period)

Exclusion criteria.

* Pelvic pain and vaginal bleeding of unknown or non-Adenomyosis causes
* Benign Lesions such as endometrial polyp, submucous Myoma or suspicious malignant tumors were diagnosed by ultrasonography
* Receiving other hormone drugs for Adenomyosis
* Use other drugs that interact with tripriline acetate and mifepristone, and can not be stopped
* Patients with severe heart, liver, kidney disease and Adrenal insufficiency; drug allergy or allergic constitution
* Participated in other clinical trials within 3 months, and other factors considered unsuitable for the trial
* Pregnant, lactating women and those who prepare for childbirth during the treatment or within six months after treatment
* Postmenopausal women.
Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate

The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides_amorphous calcium phosphate in the remineralization of dental caries.

the patients will be randomly assigned to one of three study groups the first group is nanosilver fluoride,the second is casein phosphopeptides_amorphous calcium phosphate and the third is sodium fluoride as positive control..the three material will be applied in single application with no repetition ..follow up after one and three month ..the patient should have at least one carious lesion(ICDASII code 5)

Eligibility Criteria:
* Clinical diagnosis of carious lesion
* participants should be free of any systemic diseases.

Exclusion Criteria:

* sensitivity to Silver or other heavy-metal ions or any milk-related allergies and medical conditions involving the kidneys.
* The tooth was excluded if it had pulp exposure, abscess/fistula, sensitivity to percussion
Testing of a New Scale Measuring Medical Outcomes of Dysphagia (MOD) in Adult Patients With Swallowing Disorders

Swallowing disorders (dysphagia) are common in adult patients. There is emerging evidence that dysphagia itself can cause adverse medical outcomes. There is a three-fold increased risk for pneumonia in these patients versus similar patients without dysphagia. Patients with dysphagia also suffer poor nutrition and dehydration. Patients can become so malnourished that it slows their recovery. Dysphagia can cause choking when food or liquid enters the lungs. Over time, this will cause pneumonia and even death. More acutely, patients fear that their choking will cause them to suffocate and die. Over time, patients are embarrassed to be seen choking and thus feel forced to dine alone. These patients report feelings of isolation and depression. To date, there are no practical methods to assess these adverse outcomes of swallowing difficulties in patients. This research will be the first to address this gap. Specifically, as part of previous research (PhD dissertation by RM, the PI) a new measure of medical outcomes of dysphagia was developed, titled the Medical Outcomes of Dysphagia (MOD) scale. The MOD consists of 3 subscales that each measure lung, nutrition-hydration or psychological consequences in patients with swallowing difficulties. Unlike more expensive and complex tests, the MOD has been designed for both in- and outpatients. This research will validate each MOD subscale to ensure retention of only items that are reliable and valid for use with patients who have dysphagia due to any disease etiology. The final MOD subscales will be the first to allow clinicians to track medical complications in their patients and to ensure that treatment is effective. Globally, the MOD subscales will direct limited health care resources to the most effective treatments for swallowing disorders.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years)
* Any disease etiology, including but not limited to: previous or current diagnosis of head and neck cancer (treatment may include surgery, radiation or chemotherapy, or a combination of more than one), stroke, cervical spine abnormality, brain tumour, cardiovascular surgery, and Parkinson's disease
* Current diagnosis of dysphagia, as determined by a speech language pathologist
* English-speaking

Exclusion Criteria:

* No dysphagia
* Cognitive impairment
* Limited fluency in English
Frailty and Postoperative Shock

To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015

Exclusion Criteria:

* non-traumatic hip fracture
* refusal
MyoStrain CMR for the Detection of Cardiotoxicity

The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and Lymphomas).

The study is a prospective, observational, single center, observational clinical study that will enroll up to 50 patients undergoing chemotherapy and/or targeted therapy with or without concomitant radiotherapy for the treatment of breast cancer or lymphoma. Enrolled subjects will be evaluated with the MyoStrain SENC CMR Imaging System that measures myocardial strain during standard Cardiac Magnetic Resonance imaging at baseline through 6 month follow-up.

The MyoStrain SENC CMR Imaging System has been approved with an EC Certificate according to Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 (CE 657862) in respect of: Design, development and manufacture of software for the quantification of cardiac MRI images. MyoStrain measures the contraction of heart muscle in one heartbeat per image plane. With 6 image planes (3 short axis \& 3 long axis), a complete measure of the health of the myocardium, both regionally and globally, can be obtained within a minute without requiring contrast injection or a breath-hold.

Heart health will be monitored throughout cancer therapy to quantify the toxic effects of chemotherapy with or without a reduction in traditional measures such as ejection fraction, and the ability to reverse observed cardiotoxicity with standard heart failure therapy.

The goal of the study is to determine the ability to detect subclinical cardiotoxicity before extensive damage causes the reduction in traditional measures, which are currently used to categorize heart failure and serve as the basis of treatment guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Chemotherapy for Cancer Treatment
* Provided Written Informed Consent

Exclusion Criteria:

* Contraindication to Magnetic Resonance Imaging
* Pregnancy
PNF Techniques to Improve Bed Mobility, Transfer and Early Trunk Control in Stroke Patients

Trunk control is an important factor which is disturbed after the stroke. The literature reviews suggest that trunk exercises are required to achieve good trunk stability which is essential for balance, daily functional activities and higher function tasks. By keeping these facts in view present study aims at evaluating the efficacy of PNF techniques \& conventional trunk exercise to improve trunk control in recovery stage hemiplegic patients Objective: To determine Proprioceptive neuromuscular facilitation (PNF) Techniques to improve bed mobility, transfer and early trunk control in Stroke patients

50 patients was included and allocated into 2 groups, group A consisting of 25 patients who received PNF techniques for trunk to improve trunk control. Group B consisting of 25 patients who received conventional trunk exercises to improve trunk control. Trunk control was assessed pre and post treatment with the help of Trunk Impairment Scale and ICU mobility scale. Data was collected by ICU mobility scale \& Trunk impairment scale

Eligibility Criteria:
Inclusion Criteria:

* Stroke (Acute stage)
* First attack without any prior residual impairment.
* Middle Cerebral Artery syndrome

Exclusion Criteria:

* Cognitive deficits or aphasia
* Neurological disorders e.g, Parkinson's disease.
* Heart failure
* Systemic orthopaedic and psychological disorders
Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy

To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.
* Capacity to consent

Exclusion Criteria:

* Patients unable to speak English
* Patients unable to give consent
Early Detection of Gestational Diabetes Mellitus in Pregnancy

The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.

Eligibility Criteria:
Inclusion Criteria:

* 1) age greater than or equal to 18 years old,
* 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
* 3) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
* 4) able and willing to provide informed consent,
* 5) English or Spanish speaking, and
* 6) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Exclusion Criteria:

* 1) known diagnosis of pre-existing pregestational diabetes,
* 2) plan to receive prenatal care or deliver outside of UMMHC,
* 3) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
* 4) systemic steroid use.
Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion

To evaluate the ability of cancer ratio and pleural fluid markers to discriminate between malignant and non malignant effusion

Pleural effusion is a common clinical entity affecting approximately 1.5 million patients per year in the United States. {3.1}A large number of diseases may be associated with pleural effusion.

This includes:

* Local conditions affecting the pleura (eg, tuberculous pleurisy, pleural mesothelioma),
* Extrapulmonary diseases with secondary pleural involvement (eg, chronic heart failure, liver cirrhosis).

To date, differentiation between both types of pleural effusion (exudate and transudate) is the most common initial diagnostic approach for patients with pleural effusion.

Exudative effusion is commonly seen in three conditions namely cancer (MPE), tuberculosis (TB) and para pneumonic Although MPE can be diagnosed by simple pleural fluid cytology, this method has significant limitations, including a highly variable sensitivity, ranging from as low as 11.6% to as high as 71%.

In contrast to other common causes of pleural effusion such as T.B, no accurate biomarkers of MPE have been established.

Several tumor markers were extensively evaluated, including carcinoembryonic antigen, cytokeratin-19 fragments, and cancer antigen 125, but none of them were found sensitive and specific enough to be implemented in routine clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Patients (100 cases) with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital

Exclusion Criteria:

* Age ˂ 18 years
* Refusal to participate in the study
Prenatal Iron Supplements: Safety and Efficacy in Tanzania

The purpose of this study is to determine safety and efficacy of prenatal iron supplementation in an area of high malaria burden among women who are not anemic or iron deficient.

Iron deficiency anemia and malaria are urgent public health problems in sub-Saharan Africa, including Tanzania. There is a paucity of good quality randomized trials assessing the safety and efficacy of iron supplementation in pregnancy, and its effects on perinatal health outcomes. Prenatal iron supplementation is recommended based on its demonstrated benefit in preventing and treating maternal anemia. There is limited data on the efficacy of iron supplementation on pregnancy outcomes, including birth weight. There are also concerns regarding the use of iron supplementation, particularly among non-anemic women. In particular, there is a lack of research on the safety and efficacy of prenatal iron supplementation in developing regions, characterized by extensive burden of iron deficiency, malaria, and other endemic infectious diseases. Evidence from randomized controlled trials is urgently needed to examine the safety and efficacy of iron supplements among pregnant women in malaria endemic regions, particularly among women who are not anemic.

NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* at or before 27 weeks of gestation
* primigravida or secundigravidae
* not anemic (defined as Hb\<8.5 g/dL)
* not iron deficient (defined as serum ferritin \<12 μg/L)
* HIV-uninfected
* intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.

Exclusion Criteria:

* After 27 weeks gestation
* not primigravida or secundigravidae
* anemic
* iron deficient
* HIV-infected
* High iron stores at baseline (i.e., serum ferritin \>200 μg/L)
* do not intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.