cyrilzakka/clinical-trials huggingface dataset:
Predictive Value Of Admission Blood Glucose Level In Patients With Acute Myocardial Infarction

Coronary atherosclerosis is the leading cause of death worldwide. Diabetes mellitus is associated with increased prevalence of coronary artery disease

Increased plasma glucose is a common feature in the acute phase of myocardial infarction, even in patients without diabetes. Patients with stress hyperglycemia, but without previous diagnosis of diabetes, were at increased risk of congestive heart failure, arrhythmia and cardiogenic shock as well as increased both in-hospital and long-term mortality . Previous studies have demonstrated larger infarct size and poorer prognosis inpatients with hyperglycemia upon hospital admission compared with patients without hyperglycemia

It has been reported that stress hyperglycemia impairs microvascular circulation and may lead to no-reflow phenomenon. No reflow phenomenon was significantly more frequent among patients with hyperglycemia and increased progressively with increasing admission blood glucose in patients with Acute Myocardial Infarction . Furthermore, patients with high admission glucose are more likely to develop restenosis and require repeat revascularization procedures compared with those with normal admission glucose and are also at increased risk for repeated Myocardial Infarction, stent thrombosis and death.


Eligibility Criteria:
Inclusion Criteria:

acute ST Segment Elevation Myocardial Infarction patients not known to have Diabetes Mellitus undergoing primary PCI.

Exclusion Criteria:

* patients known to have Diabetes mellitus (known diabetes mellitus on admission, which was treated with diet, oral glucose-lowering medication, and/or insulin).
* Patients with prior Primary Percutaneous Intervention and/or Coronary Artery Bypass Graft (altering disease state).
* Patients with severe liver or renal disease (altering disease state).
* Patients with anemia, kidney disease or certain blood disorders (thalassemia).
Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis

In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.

In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged of 2 days to 12 months
* Indication of a sweat test prescribed by a clinician in a context of neonatal screening
* Clinically stable
* Well hydrated
* Not under treatment with mineralocorticoids

Exclusion Criteria:

* Subjects weighing less than 2 kg
* Subjects less than 48 hours old
* Presence of an acute infectious condition
* Presence of mineralocorticoid treatment
The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea

The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:

* RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?
* RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?
* RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?

All wards in Bauchi state will be randomly assigned to one of two groups:

* treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
* delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.

A total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least 15 years old
* Has at least one child under 5 at baseline
* Proficiency in English or Hausa

Exclusion Criteria:

* Living in a temporary home (nomadic population)
* Does not speak English or Hausa
* Unable to give informed consent
Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children

This study is looking at the effects of giving early treatment of deferiprone to young children with beta thalassemia who have started receiving regular blood transfusions but have not yet reached the criteria for starting on iron chelation therapy. Half the patients in the study will receive deferiprone, and the other half will receive placebo, for up to 12 months.

This study will give deferiprone to infants and young children with thalassemia who have started receiving regular blood transfusions but whose iron load is not yet at the level where chelation treatment would normally begin. The purpose is to see if doing this will postpone the build-up of iron without causing serious side effects. Half the children in the study will be given deferiprone at a dose that is lower than what is normally prescribed, and the other half will be given placebo. All patients will receive the assigned product three times a day for up to 12 months. Tests for signs of iron overload will be done monthly, and a patient whose iron load reaches the level where chelation therapy would normally begin will be immediately taken out of the study and started on standard chelation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 6 months to \< 10 years
2. Confirmed diagnosis of beta-thalassemia, as determined by high performance liquid chromatography (HPLC) or DNA testing
3. Started on a red blood cell (RBC) transfusion regimen, with a minimum of 2 transfusions already completed
4. Screening level of serum ferritin (SF) greater than \>200 μg/L but not more than 600 μg/L. Since SF level may be impacted by the presence of infection, it must additionally be verified that the child has had no signs of infection in the previous 7 days, including the day of screening, and that the level of C-reactive protein (CRP) is no greater than 20% higher than the normal range for the patient's age. If there are signs of infection and/or the CRP level is above this threshold, the SF level must be checked again a minimum of one week later.

Exclusion Criteria:

1. Prior use of iron chelation
2. Diagnosis of hepatitis B or C, or HIV infection
3. Evidence of abnormal liver or kidney function at screening: serum alanine transaminase (ALT) level \> 5 times upper limit of normal or creatinine levels \>2 times upper limit of normal
4. Disorders associated with neutropenia (absolute neutrophil count \< 1.5 x 10\^9/L) prior to the initiation of study medication
5. A serious, unstable illness, as judged by the investigator, during the previous 3 months before screening/baseline visit including but not limited to hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease.
6. Presence of any medical condition which in the opinion of the investigator would cause participation in the study to be unwise.
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Patients with SNF34subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of Apatinib in SNF4 subtype of HR

+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥18 years and ≤ 75 years old;
* Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, PR\> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
* Subtype of similarity network fusion-4 (SNF-4) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
* Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
* Patients had received no previous chemotherapy or targeted therapy for metastatic disease

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* Has adequate liver function and kidney function: serum creatinine
* ECOG score ≤ 2 and life expectancy ≥ 3 months;
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up

Exclusion Criteria:

* Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
* Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
* Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
* is pregnant or breast feeding;
* Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
Health Effects of Cetoleic Acid (A Randomized Double Blinded Controlled Trial)

In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control).

Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.

This is a randomized double-blinded controlled trial ( randomized 1:1). Study population: healthy men and women 20-70 years, BMI 20-35 kg/m2.

Study design:

* 3 weeks run-in-period where all participants consume control capsules every morning.
* Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.

The intervention oil consists of a fish oil high in cetoleic acid and the control oil is a mix of different oils and low in cetoleic acid.

Power calculation and sample size:

It was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).

The level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).

Eligibility Criteria:
Inclusion Criteria:

* BMI 20-35kg/m2
* opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.

Exclusion Criteria:

* Chronic disease (liver/kidney/metabolism)
* Alcohol overconsumption (\>40g/day)
* Diabetes and high fasting blood glucose
* Pregnant/ breastfeeding or planning pregnancy during the study period
* High fish intake (\>3 meals/week).
* Blood donation during the study period
* Difficulty following the study protocol.
* Smoking/snuffing
* Regularly use of anti-inflammatory drugs
* Regularly use of omega-3 supplements /cod liver oil.
Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden

Cross-sectional comparative study of general and stoma-specific quality of life in patients with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.

Objective: To evaluate the quality of life for patients with ostomy in Ethiopia and Sweden using a general and a specific assessment tool.

Design: Comparative descriptive cross-sectional study. Setting: Tikur Anbessa Specialized Hospital (TASH), Addis Abeba and South General Hospital, Stockholm.

Participants/Exposure: Patients with a permanent ostomy visiting the stoma center in Addis Abeba, patients waiting for ostomy reversal at TASH, and patients visiting the stoma clinic at South General Hospital.

Main outcomes and measure: Quality of life and stoma specific quality of life: EQ5D-5L and Stoma QoL.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥ 18 years old)
* having an ostomy for more than two months
* willingness and ability to give informed consent

Exclusion Criteria:

* non-intestinal stoma
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants

The purpose of this study is to assess the safety and tolerability of guselkumab following single-dose intravenous (IV) infusion in Japanese healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
* Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
* Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study, if the inpatient site allows. However, if smoking is not allowed in the inpatient site, smokers will not be allowed to smoke while inpatient cannot use nicotine replacement products during the inpatient period, but may smoke at other times during the study, up to the maximum stated above
* Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol per day for the duration of the study

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Any medical contraindications preventing study participation
Addressing Hospital Patient Information Needs Using Information Technology

The aim of this study is to evaluate the impact of an inpatient personal health record (PHR) portal intervention within the hospital environment. The intervention hopes to improve patient engagement with their care and to measure patient activation and satisfaction. Additional clinical measure (e.g. number of adverse events that occur during the stay, changes to medication orders, etc.) will also be studied. Characterization of hospital patient and clinician attitudes towards patient engagement will also be formalized.

This study will utilize an enhanced inpatient PHR portal to allow patients to view their care team, documented allergies and medications (home and hospital) as well as electronically document questions and concerns related to their care. These questions and concerns are visible to members of the patients' care teams within our commercial inpatient electronic health record (EHR). We will study the impact of the technology using a randomized trial of 426 cardiology and cardiothoracic surgery patients at Columbia University Medical Center in Upper Manhattan. We hypothesize that the use of the inpatient PHR portal will identify and address patients' information needs, improve patient activation, engagement and satisfaction, and encourage PHR use after hospital discharge. We also hypothesize that information entered by patients into the PHR portal will be useful to clinicians. There is no compensation for participating in this study.

The specific aims of the proposal are to:

Aim 1: Evaluate the impact of an inpatient PHR portal intervention using a randomized controlled trial. The primary outcomes will be patient activation, engagement and satisfaction. We will also determine whether access to the inpatient PHR portal is correlated with greater use of the PHR after hospital discharge.

Aim 2: Characterize information needs of hospital patients and assess clinicians' attitudes toward patient engagement in the hospital setting. We will analyze the questions and comments that patients record within the PHR portal application and assess the salience of patient-entered information to issues of care quality and safety. This aim will expand our previous work in taxonomy development and hazard and near-miss recognition. A survey will be administered to collect clinicians' perceptions of the barriers to and facilitators of system use. EHR documentation will be reviewed to assess whether patient-entered information was acknowledged by clinicians, and whether changes were made to the patient's plan of care as a result.

Eligibility Criteria:
Inclusion Criteria:

* Speaks English or Spanish
* Admitted to unit where study is ongoing

Exclusion Criteria:

* Does not pass Mini-mental status exam
A Trial on Treatments of Hirschsprung Allied Disease

The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Eligibility Criteria:
Inclusion Criteria:

* hard or firm stools for twice or less per week
* a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Exclusion Criteria:

* functional constipation
* a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains

The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.

The purpose of this protocol is to assess the effects of grade IV anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.

Eligibility Criteria:
Inclusion Criteria:

* Incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt
* Slight reduction in function
* Anterolateral ankle tenderness
* Dorsiflexion ROM asymmetry greater than 5° compared to uninvolved limb
* Posterior talar glide restriction greater than 5° compared to uninvolved limb; or
* Posterior talar glide less than 19°, which is one standard deviation (7°) from our previously established normative values (26°)9, 10
* Suffered from grade 1 or 2 lateral ankle sprain within the last 48hr - 8 days

Exclusion Criteria:

* A history of ankle surgery that involves intra-articular fixation,
* Syndesmotic ankle sprain (to be ruled out based on clinical examination),
* History or signs of reflex sympathetic dystrophy,
* Have received manual therapy for the ankle sprain prior to enrollment
* Grade III ankle sprain.