cyrilzakka/clinical-trials huggingface dataset:
Text Messaging Follow-up From ED

Ensuring follow-up for patients after discharge from the emergency department (ED) has long been a concern for ED care providers. The current technology of text messaging may be able to assist us in improving follow-up rates. In addition, having a quick and easy communication tool to be in touch with providers may improve overall patient satisfaction. This study is designed to evaluate the usage of text messaging to improve follow-up appointment compliance from the Emergency Department. In this study, a prospective randomized controlled trial (RCT) will be performed (involving patients scheduled by Emergency Department Nurse Navigators to follow up with Family Medicine) in which patients will be randomized to a texting appointment reminder versus standard-of-care (no texting reminder) group. Texted patients will receive reminders 3 days and 1 day prior to their follow-up appointment. In addition, the patients will have the ability to text back-and-forth with the Nurse Navigators in order to ask questions/request clarification if needed. Chart review will be performed of both groups to evaluate the number of follow-up appointments that patients attended versus rescheduled versus did not attend/reschedule. These values will then be compared to the retrospective chart review previously performed to evaluate for non-inferiority of text messaging as a means of improving patient attendance at follow-up appointments.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Able to read, write and communicate in English - English as the primary language
3. Has a phone with capabilities for text messaging
4. Identifies oneself as someone who is comfortable with text messaging.
5. To follow-up with Family Medicine as outpatient (Scheduled through Emergency Department Nurse Navigators).
6. Evaluated in the University of Iowa Hospitals and Clinics Emergency Department

Exclusion Criteria:

1. Absence of one or more inclusion criteria
2. Not able to provide informed consent or participate due to limited decision-making ability.
3. Prisoner
4. Previously has followed with the University of Iowa Hospitals and Clinics Family Medicine (i.e., would not be a "new" patient establishing care).
The Application of Time-lapse System in IVF/ICSI

Nowadays, the rapid development of human assisted reproductive technology (ART) has provided many help for couples with fertility issues. Even take baby home rate has been increased dramatically in the past several decades; both clinicians and embryologists are still struggling to improve pregnancy rates. Among all the strategies that the embryologists have tried, much work has been done to find better embryo culture conditions and embryo quality evaluation system. Currently, most centers in the world, including ours, are still using conventional incubators and manual embryo scoring system. This traditional method has several limitations, such as unstable environment during culture, and embryo scores can be different judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse embryo culture and analysis system. It is user-friendly, and suited for routinely daily use. In addition, its KID Score system can help embryologist select high quality embryos quickly, which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this prospective cohort study is to evaluate the use of EmbryoScope® in our center.

All patients included into this study are divided into three groups:

1. Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.
2. Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.
3. Conventional Group: All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.

The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate, cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.

Eligibility Criteria:
Inclusion Criteria:

* First IVF/ICSI cycle;
* With normal ovarian reserve(FSH \< 10 mIU/mL; antral follicle count\>5);
* Age under 38 years old;
* With normal uterine;
* Tubal factor infertility

Exclusion Criteria:

* Pre-implantation genetic diagnosis cycles;
* Oocyte donation or sperm donation cycles.
Examining Tolerance to CNS Stimulants in ADHD

Although stimulant medication is a well-established treatment for ADHD, it is often necessary for doctors to increase the dose over time to maintain the benefits of the medication. While medication can be very effective for improving symptoms of ADHD during the first year of use, it has not been found to significantly improve the long term course of children with ADHD. For example, in large research studies, groups of children who take medication for ten years do not have consistently better academic grades than groups of children who never used medication (individual results will vary from child to child).

In order to help children with ADHD achieve the best possible outcomes, it is important for doctors to study why this happens. One possible reason is development of tolerance to the medication. Tolerance means that a drug's effects decrease when it is taken consistently over time, so that an increased dose is needed to continue showing effects. Some doctors believe that children who take stimulant medication for ADHD develop tolerance to it which would explain why benefits may not persist over time, but no research studies have been done to measure whether this occurs. This study aims to see if children show a tolerance effect to stimulant medication and whether that tolerance can be prevented by taking short breaks from the medication called medication holidays.

This is an innovative evaluation of tolerance using an objective measure in an analog classroom. Each subject will complete the a 10-minute math test twice a day for three weeks on optimal dose or placebo, and then be crossed over to the other condition. Within-subject drug/placebo differences will be compared over the three weeks of exposure to assess tolerance in the analog setting.

When school commences, 50% of the sample will be randomized to 7-day-a-week (continuous) dosing and 50% to 5-day-a- week (weekend holidays) dosing to examine the efficacy of prescribed weekend drug holidays for combatting need for dose escalations (tolerance) during the school year.

Participants will be assessed monthly to detect deteriorating functioning. Using a standardized protocol, study physicians will increase dose for subjects in either arm who meet defined impairment thresholds. The difference between the two dosing conditions will inform regarding how best to deal with tolerance in clinical application.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of attention-deficit/hyperactivity disorder
* Full Scale IQ above 80

Exclusion Criteria:

* Psychotropic medications for conditions other than ADHD
* Active medical or psychiatric conditions that could be worsened by stimulants
* Diagnosis of Autism or Asperger's Disorder
* Documented intolerance fo methylphenidate or failed trial of OROS MPH
Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.

Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.

Eligibility Criteria:
Inclusion Criteria:

* Age group for six months - 5 years.
* No or mild to moderate dehydration.
* Alert patient (to tolerate oral intake since the drug is only available in oral form).

Exclusion Criteria:

* Patients with severe dehydration (inability to drink because of drowsiness).
* Patients with any serious concomitant illness that needs antibiotic treatment.
* If severe adverse events occur at any time.
* Chronic diarrhea.
Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer

Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.

Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality.

Endocrine therapies with/without target therapy including CDK4/6 inhibitors or mTOR inhibitors are the mainstay of 1st line treatment for ER-positive/HER2-negative metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

-ER-positive/HER2-negative in primary tumor

* Oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
* Recurrent cancer after completion of primary treatment (RFI≥1year)
* Metastatic lesions are feasible for resection or radiotherapy (Size≤3cm)

Exclusion Criteria:

* De Novo metastatic cancer at initial diganosis
* Recurrence-free inverval \< 1 year
A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL \[EMZL\], splenic MZL \[SMZL\], nodal MZL \[NMZL\], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists
* Eastern Cooperative Oncology Group Performance Status of 0 to 1

Exclusion Criteria:

* Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered
* Symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages
* Impaired cardiac function or clinically significant cardiac diseases
* Poor bone marrow reserve as assessed by Investigator

Refer to protocol defined exclusion criteria for parts C and D. Other protocol-defined inclusion/exclusion criteria apply
Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen

Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.

This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5 without any signs of infections will be enrolled in this study. Patients will be randomly divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group will receive placebo twice daily.

Patients in each group will be monitored for body temperature at baseline (at the time of enrollment) and at 1, 2, 4, 6, 8, 24 h after receiving the tested material.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Body temperature between 37.8-38.5
* Body weight not less than 40 kg but not over 100 kg
* Liver enzymes do not exceed 2 times of normal value
* Can comply with study protocol

Exclusion Criteria:

* Have allergic history of any tested compounds
* Fever from other causes, not by URI
* Take any herbal medicines during 2 weeks before enrollment
* Physicians decide to withdraw the subjects with any reasons
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55
* Clinically stable Schizophrenia and predominant negative symptoms
* Taking a stable dose of antipsychotic medication

Exclusion Criteria:

* Clinically notable positive symptoms defined by PANSS
Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.


Eligibility Criteria:
Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 75 years；
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
4. HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
5. Primary breast cancer;
6. Known hormone receptor status.
7. The organs are functioning normally, like the liver function, the renal function， and the baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
8. Signed informed consent form (ICF)

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer
2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. A history of allergy to the drugs in this study；
5. Unable or unwilling to swallow tablets
Fluvastatin in the Therapy of Acute Coronary Syndrome

This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.


Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome
* Adults, 18 years and older

Exclusion Criteria:

* History of lipid lowering therapy less than 30 days before index event
* Pregnancy and nursing
* Subject younger than 18 years

Other inclusion and exclusion criteria may apply.
Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

This study aims to compare changes in cardiovascular function and markers of inflammation and metabolic dysfunction in women randomized to treatment with extra virgin olive oil (EVOO) versus those randomized to treatment with a control oil low in oleic acid and phenols for 8 weeks.

Participants will be randomized to receive 45 ml (40 g) of extra virgin olive oil (EVOO) daily for 8 weeks or an identical dose of a control sunflower seed oil low in oleic acid and phenol content. EVOO high in oleic acid and phenolic content will be identified and shipped from Italy and stored protected from heat and light in the Bionutrition Core at the Clinical Research Center at the University of Vermont Medical Center. Women will undergo a detailed cardiovascular assessment at baseline and following treatment, including assessment of blood pressure, pulse-wave velocity, calculation of arterial distensibility and beta stiffness, flow-mediated vasodilation, cardiac output, response to volume challenge and dual-energy X-ray absorptiometry (DEXA). Lipid profiles and markers of inflammation, oxidative stress and metabolic dysfunction will also be assessed at both study visits.

Investigators hypothesize that treatment with high oleic acid and phenolic EVOO will be associated with decreased blood pressure, improved vascular compliance and blood vessel function, and with improvement in lipid profile, inflammation and markers of metabolic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Women are eligible to participate if they are between the ages of 18 and 40, in good health, with regular menstrual cycles and no prior pregnancies.

Exclusion Criteria:

* Routinely take medications or supplements known to affect blood pressure, heart or blood vessel function, or those with anti-inflammatory or antioxidant properties
* Smoking
* Pregnancy
* Other conditions that would impair adherence, such as allergy to olive oil or sunflower oil or difficulty swallowing
Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes

Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. Nordic walking (NW) and high-intensity interval training (HIIT) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional MICE. The main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including NW and HIIT on exercise capacity, quality of life and depression after a 12-week program.


Eligibility Criteria:
Inclusion Criteria:

* Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks);
* Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program;
* Patient is able to walk independently
* Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
* At least 40 years of age;
* Patient is willing and able to provide informed consent

Exclusion Criteria:

* Currently participating in routine exercise training (\>2x/week) and/or using Nordic Walking poles;
* Active infection or inflammatory condition;
* Over 75 years of age;
* Persistent or permanent atrial fibrillation;
* Pregnant, lactating or planning to become pregnant during the trial period;
* Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
* Unable to read and understand English or French;
* Unwilling or unable to return for follow-up visit at weeks 12 and 26;
Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products

The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products cardiovascular risk factors in hypertriglyceridemic patients.

Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart diseases.

As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination by their general practitioners. Fifty-one hypertriglyceridemic patients (25 f, 26 m; with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) entered the study.

The placebo-controlled, randomized double-blind cross-over study consisted of two investigation periods of 15 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 15 weeks. Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils (fish oil, rapeseed oil) with high amounts of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA). The daily dose of n-3 FA amounted to 3.3 g, consisting of 1.5 g EPA, 1.2 g DHA, 0.2 g DPA, and 0.2 g ALA.

Venous blood and 24h urine were collected at the beginning and at the end of each period.

Eligibility Criteria:
Inclusion Criteria:

* TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L

Exclusion Criteria:

* blood diluted medications
* lipid lowering medications
* glucocorticoids
* gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
* daily alcohol abuse
* taking dietary supplements (e. g., fish oil capsules, vitamin E)
* known allergies or foodstuff indigestibility
HealtheTech Lifestyle Program

The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using BodyGem and BalanceLog in helping overweight and obese individuals manage their weight.

The study plans are to develop and test the efficacy of a practical, structured, and time-limited behavioral intervention (HealtheLifestyle Program) as a supplement to standard HealtheTech products. Approximately 130 participants will be recruited and randomized to either the HealtheTech Program (focusing on calorie and exercise goals using the BalanceLog for tracking), the HealtheLifestyle Program (using step counters, monthly email letters and calls providing information on activity, nutrition, and weight loss), or a delayed treatment program (after 3 months undergo the intervention above).

Eligibility Criteria:
Inclusion Criteria: healthy adult men and women, 18-60 years -

Exclusion Criteria: not currently participating in a structured diet or exercise program

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