cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.

It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or more.
* Early term singleton pregnancy.
* Elective caesarian section at (37 - 38+6) weeks of gestation.
* Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction).
* Informed written consent signed by the participating pregnant woman.

Exclusion Criteria:

* Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma.
* Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study.
* Pregnancies of known fetal diseases or chromosomal abnormalities.
* Non-singleton pregnancies.
* Emergency caesarian section as in ruptured membrane and women in labor pain.
A Study to Investigate the Effects on Blood Pressure and Pulse Rate of a Single 100mg Dose of Sildenafil in Patients With Benign Prostatic Hyperplasia Who Are Being Treated With Doxazosin

To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH). To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg, and to investigate the safety and toleration of sildenafil 100 mg when co-administered with doxazosin.


Eligibility Criteria:
Inclusion Criteria:

* patients who weighed between 132 and 220 lb (60 and 100 kg) with benign prostatic hyperplasia (BPH)
* a total PSA (prostate specific antigen) measurement of less than or equal to 10 µg/L within the 12 months prior to screening, were currently on doxazosin treatment for BPH, had been treated with doxazosin for a minimum of 2 months prior to first dose of study medication, and had received a minimum of 4 mg doxazosin once daily (from doxazosin supplied for this study) for 2 weeks prior to the first dose of study medication.

Exclusion Criteria:

* subjects with a recent history (i.e. within 6 months prior to screening) of stroke or myocardial infarction
* subjects with severe cardiovascular disorders such as unstable angina or severe congestive heart failure
* subjects with known hereditary degenerative retinal disorders, such as retinitis pigmentosa
* subjects with a supine systolic/diastolic blood pressure of \>170/100 mmHg or \<100/60 mmHg either at screening or at the pre-dose measurements
* subjects receiving any other antihypertensive therapy other than doxazosin in the 3 weeks prior to the first dose of study medication.
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes

As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide. In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide. This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least 1 year history of type 2 diabetes mellitus.
* Subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening HbA1c ≥7.0% and ≤10.0%.
* Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.

Exclusion Criteria:

* Within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
* Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
* Subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
* Subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. Anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
* Subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
* Blood donation of more than 500 mL in the last 3 months of screening or any blood donation within the last month.
A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

1. On the day of signing the informed consent form, the age should be between 18 and 75 years old.
2. At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
3. The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
4. Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.

Exclusion Criteria:

1. At the screening period, relevant laboratory test results are abnormal.
2. Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
3. Uncontrolled severe hypertension at the screening period.
4. Presence of endocrine diseases that may significantly affect the body weight.
5. History of acute or chronic pancreatitis.
6. History of significant gastrointestinal diseases.
7. Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
8. Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
9. Known or suspected abuse of alcohol or narcotics.
10. Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.
Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.

The aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the FDG PET exam.

The objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. The subjects will represent different decades of age to have a wider range of comparison with patients.


Eligibility Criteria:
Inclusion Criteria:

* absence of neurological and psychiatric pathologies, negative pregnancy test.
Study of Rocuronium Onset Time According to Remifentanil Infusion

The investigators therefore hypothesized that remifentanil could prolong the onset time of rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial pressure and heart rate) during the anesthetic induction sequence.

It has been reported that co-administration of ephedrine reduced the onset time of neuromuscular block of rocuronium (1-3). It also provided an improved condition for the rapid tracheal intubation (2,4). This beneficial effect was attributed to the increased cardiac output and tissue perfusion to muscle, and therefore, a more rapid delivery of rocuronium to the neuromuscular junction was achieved (4-5). If so, any drugs which decrease cardiac output consequently can prolong the onset time of rocuronium.

Remifentanil is the first ultra-short acting opioid with a rapid onset. During the total intravenous anesthesia (TIVA) with propofol and remifentanil, prior administration of remifentanil could reduce the propofol infusion pain without other significant complications (6). However, remifentanil can decrease the arterial pressure and heart rate (7-8), so that it is likely to decrease the onset time of rocuronium for the opposite principle that ephedrine increases it.

The investigators therefore hypothesized that remifentanil could prolong the onset time of rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial pressure and heart rate) during the anesthetic induction sequence.

Eligibility Criteria:
Inclusion criteria:

* American Society of Anesthesiologist physical status I or II
* Aged 20-65 yr
* Elective surgery under general anesthesia with total intravenous anesthesia
* 8.5 kg/m2 \< body mass index (BMI) \< 25 kg/m2

Exclusion criteria:

* BMI \> 25 kg/m2 or \< 18.5 kg/m2
* Any cardiovascular or neuromuscular disease
* Intake of drugs known to interact with the neuromuscular junction
* Patients wit risk of pulmonary aspiration
* Anticipated difficult airway
* history of known allergy to rocuronium
Trim Tots Pre-school Obesity Prevention Programme

Randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.
Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
* Tumor/disease lesions that can be measured bidimensionally.
* Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
* Adequate recovery from recent surgery or radiation therapy.
* Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
* Accessible for treatment, follow-up and required visits at a participating center(s).

Exclusion Criteria:

* Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
* Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
* Prior severe infusion reaction to antibody therapy.
* Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
* Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
* Serious uncontrolled medical disorders that would impair the ability to receive therapy.
* History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
* Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
* Peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event \[CTCAE\] Version 3.0).
* Inadequate hematologic and/or liver and/or kidney function.
* Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment prior to study drug administration.
* Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.
Liver Fibrosis in Sickle Cell Disease

Patients with sickle cell disease many have a number of systemic complications, including liver problems. Some of these liver problems lead to liver fibrosis/cirrhosis, secondary to chronic blood transfusions. The purpose of this study is to investigate FibroScan readings in patients with sickle cell disease and iron overload secondary to blood transfusions, and to correlate the FibroScan results with Ferriscan. A comparison with the results of FibroScan to patients with Sickle cell without known liver disease, who have never been on chronic transfusions and with normal liver function profiles will also be made.The primary hypothesis is that the results of FibroScan will correlate with the results of Ferriscan and liver biopsy.

Liver biopsy is the gold standard to examine the liver for iron deposits and histology. However, liver biopsy is invasive and involves a risk of bleeding and pain. Biopsy may also miss significant pathology if the small biopsy specimen is taken from an uninvolved part of the liver. Non-invasive techniques such as MRI are now used to evaluate the liver iron content. MRI can visualize the whole liver and measure liver iron content. MRI, however, will not detect liver scarring.

Liver transient elastography (FibroScan) is a non-invasive ultrasound tool for assessing liver fibrosis or scarring by measuring liver stiffness (LSM). Compared with liver biopsy, FibroScan provides immediate results and is a painless, short (3 mins), simple procedure to perform. In some studies FibroScan reports have correlated well with liver biopsy results of fibrosis and cirrhosis, and with Ferriscan, ferritin and liver function tests.

This purpose of this study is to investigate the role of FibroScan in individuals with sickle cell anemia and iron overload or who have a diagnosis of liver disease, and to compare FibroScan readings with magnetic resonance imaging.

We will also compare the results of the Fibroscan with liver biopsy.

This study will also compare the results of FibroScan to patients with Sickle cell without any known liver disease, who have never been on chronic transfusions (defined as no more than 4 transfusions in lifetime) and who have normal liver function profiles.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients age 10 years and older with sickle cell disease
* meeting other criteria:

  1. history of chronic transfusion and iron overload and/or
  2. known liver disease related to sickle cell or iron overload
* signed consent and assent (as applicable)

Exclusion Criteria:

* children younger than 10 years
* Pregnant females
* Prisoners
* Other causes of liver disease, unrelated to sickle cell or iron overload

Inclusion criteria for controls:

* Patients 10 years and older with sickle cell disease without history of chronic transfusions (less than 4 transfusions in a lifetime)
* and without obvious liver disease.
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People

Early identification of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV is difficult, however, because 24-61% of HIV co-infected individuals with pulmonary TB have negative TB test results. In addition, conventional testing can take 6 weeks or longer and may not be available at all in many settings. This study is being conducted to see whether some new tests for identifying TB and for identifying resistance to TB drugs are at least as accurate as the current testing methods when used on HIV-infected individuals. The study will also assess whether the new tests can provide accurate results faster than the current methods.

Early diagnosis of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV can be a particular challenge, however, because 24-61% of HIV co-infected individuals with pulmonary TB are smear-negative. Conventional solid media-based culture can take 6 weeks or longer for mycobacterial growth, and may not be available at all in many settings. The purpose of this study is to determine whether new tests for identifying TB and resistance to TB drugs are as effective as current tests and if these new tests can provide accurate results faster than the current method of testing for TB and drug resistance.

This trial will enroll HIV-infected individuals who are suspected to be co-infected with TB. Participants may be in this trial for up to nine months, depending on their test results. During the study, participants will provide one or two sputum samples, have a chest x-ray, and may have blood collected.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, as documented at any time prior to study entry by a rapid HIV test or any licensed ELISA test kit
* Probable or confirmed pulmonary TB at the time of enrollment
* Current use of an anti-TB regimen for treatment of active TB for fewer than 7 days prior to sputum sample collection or anticipated initiation of same within 30 days after study entry
* Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria

* Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to sputum collection
* Inability to provide sputum sample
Optimization Lumbar Puncture In Children

The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.

The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP),less postoperative complications and comfortable LP will be anticipated.

Eligibility Criteria:
Inclusion Criteria:

* children with indications of lumbar puncture;
* voluntarily signed the informed consent

Exclusion Criteria:

* topical anesthetic skin allergies;
* skin infection in lumbar puncture site;
* severe intracranial hypertension;
* unstable vital signs;
* coagulopathy;
* intracranial hemorrhage and occupying;
* low back pain;
* headache and low back pain before lumbar puncture;
* past headache after lumbar puncture;
* mental retardation, neuropsychiatric symptoms;
* children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);
* the case with repeated puncture in one operation
Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy

The overall objective of the HEAT study is to determine the acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism and to evaluate the consequences of the change of hyper- to euthyroidism on metabolism during the course of treatment, especially with regard to the reaction to cold ambient temperatures.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Age 18 to 70 years
* Hyperthyroidism: Thyroid-stimulating Hormone (TSH) below 0.2 mU and free T4 at or above 25 pmol/L or free T3 at or above 8 pmol/L.

Exclusion Criteria:

* Contraindications to propranolol: hypersensitivity or allergy
* Therapy with a beta blocker for reasons other than hyperthyroidism (e.g. cardiac arrhythmia or heart failure)
* Treatment with amiodarone
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* History of asthma or chronic obstructive pulmonary disease
* Occlusive peripheral artery disease; Raynaud's syndrome.
* Other clinically significant concomitant disease states:

  * Known renal failure (GFR \< 50 ml/min)
  * Known hepatic dysfunction
  * known heart failure or unstable angina pectoris
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
* ECG-criteria

  * Resting heart rate below 60 bpm
  * Complete left bundle branch block
  * Atrioventricular block (AV-block) grade 2 or 3
Biomarkers During Pregnancy

This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women.

This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women. Our population is unique compared to published studies and contains significant numbers of African American women and overweight or obese women. Two of these markers have been examined in several other populations of pregnant women and have shown utility for both outcomes. However, the recommended levels of these markers need to be determined in specific populations as ethnicity and BMI affect the values. Values obtained in recruited women will be compared with biobank samples from women who have no evidence or history of diabetes. Additionally, two other potentially promising markers will be examined (beta-hydroxybutyrate and triglycerides). Both these analytes change during pregnancy and beta-hydroxybutyrate has shown correlation with large for gestational status or macrosomia in some studies. A combination of markers may be a better predictor of adverse neonatal outcomes than a single marker.

Eligibility Criteria:
Inclusion Criteria:

* All women included in the study will either have diabetes diagnosed before pregnancy or will have been diagnosed during pregnancy (GDM). We do not exclude minors, since in Missouri, they may consent to medical treatment without parental consent for medical issues relating to pregnancy,

Exclusion Criteria:

* No specific exclusion criteria will be used. BMI data will be collected and utilized to sort patients into various subgroups, but will not be used as exclusion criteria.