cyrilzakka/clinical-trials huggingface dataset:
A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)

The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.

Participants who meet eligibility requirements will enter the single-blind Filter Period. Participants with either sitting systolic blood pressure (SiSBP) or sitting diastolic blood pressure (SiDBP) \>=95th percentile for gender/age/height will be administered either losartan 25 mg or losartan 50 mg depending on body weight (\<50 kg and \>=50 kg, respectively). After 3 weeks, if SiSBP or SiDBP is \>=95th percentile, participants will titrate to either losartan 50 mg or 100 mg according to weight. Participants with both SiSBP and SiDBP \<95th percentile will be excluded from the study. After an additional 3 weeks, participants whose blood pressure (either SiSBP or SiDBP) remains \>=95th percentile will then enter the double-blind phase. Participants who meet all entry criteria will be randomized in a 1:1 fashion to either losartan or losartan/hydrochlorothiazide (HCTZ) for 4 weeks and will be stratified according to body weight (\<50 kg and \>=50 kg). Participants whose weight is \<50 kg will be randomized to losartan 50 mg or losartan50 mg/HCTZ 12.5 mg. Participants weighing \>=50 kg will be randomized to losartan 100 mg or losartan/HCTZ 100 mg/12.5 mg. At the end of double-blind treatment, participants may enter a 20-week double-blind extension and will continue on their randomized therapy with losartan or losartan/HCTZ.

40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male/female and 6 to 17 years of age at the time of study with hypertension (high blood pressure)
* Patient is able to swallow tablets
* Females of child bearing potential must use acceptable contraception throughout the trial

Exclusion Criteria:

* Patient has a history of heart, metabolic or kidney disease
* Patient has a history of known heart, lung, liver and other body system disorders
* Patient is pregnant or nursing
* Patient has participated in another clinical trial within the last 28 days
BIO-PREDISC-TIA SWISS Cohort Study

This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting \<24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.

  * At least 18 years old.
  * Having given their Informed Consent.

Exclusion Criteria:

* · Patients with ocular TIA (Amaurosis fugax).

  * Patients that still have neurological deficits at the moment of inclusion.
  * Contraindication to perform MRI.
  * For women: pregnancy.
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Rosuvastatin Calcium Tablets Under Fed Conditions

Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in Healthy Human Volunteers Under Fed Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  * Clinically significant abnormal ECG or Chest X-ray.
  * Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  * Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
  * Respiratory rate less than 12/minute or more than 20/minute
  * History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  * History of alcohol or drug abuse
  * Positive breath alcohol test
  * Recent history of kidney or liver dysfunction.
  * History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  * Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  * History of heart failure.
  * HIV, HCV, HBsAg positive volunteers.
  * Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
  * Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  * Administration of any study drug in the period 0 to 3 months before entry to the study.
  * History of significant blood loss due to any reason, including blood donation in the past 3 months.
  * History of pre-existing bleeding disorder.
  * Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  * Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Thermosoftening of Double-lumen Tube to Reduce Sore Throat

The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Preoperative hoarseness or sore throat
* History of upper airway diseases
* Anticipated difficult airway
* Anesthesia time longer than 6 hours
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement

TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.

Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire.

TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.

Eligibility Criteria:
General Inclusion Criteria:

* Age: 18-75 years old
* Subjects with coronary artery disease
* Able to understand and provide signed consent

Angiographic Inclusion Criteria:

* Subject has an intermediate stenosis in a native coronary vessel
* The target stenosis has a reference diameter ≥2.50 mm by visual assessment.

Exclusion Criteria:

General Exclusion Criteria:

* Acute ST-elevation or non-ST-elevation myocardial infarction
* Severe heart failure (NYHA≥IV)
* Left ventricular ejection fraction \<30%
* Allergy to adenosine triphosphate (ATP)
* Contraindications for percutaneous coronary intervention (PCI)

Angiographic Exclusion Criteria:

* Target vessel has angiographically visible or suspected thrombus
* Angiographic evidence of a dissection
* Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Eligibility Criteria:
Inclusion Criteria:

* Completed original protocol, Study No. CTCH346A2211
* Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained

Exclusion Criteria:

* Exclusion criteria as described in the original protocol will remain applicable into the extension protocol

Other protocol-defined exclusion criteria may apply.
Newborn Screening for Critical Congenital Heart Disease

Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.

This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 12 hours -2 weeks.
* Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
* Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)

Exclusion Criteria:

* Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Ca:Mg Ratio and Cognitive Function

Between 2000 and 2015, mortality due to Alzheimer's disease (AD) increased by 123%. No drugs have yet been approved to stop or slow the progression of AD. A delay of five years in the expression of AD would reduce the incidence rate by half. Thus, it is critical to develop novel prevention strategies to delay the onset of this common disease.

As an ancillary study conducted within a precision-based randomized trial (R01CA149633; PI, Dai \& Yu\]"), the investigators reduced Ca:Mg ratios to 2.3 through 3-month personalized Mg supplementation among those who consumed high Ca:Mg ratio diet, but otherwise in good general health. The investigators test the hypothesis that actively reducing the Ca:Mg ratio among those aged \>65 years who consume high Ca:Mg ratio diets improves cognitive function compared to the placebo arm. The investigators further conduct molecular epidemiologic studies to understand the molecular mechanisms.


Eligibility Criteria:
Inclusion Criteria:

1. Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
2. Participants who completed the MoCA

Exclusion Criteria:

1. Participants did not provide their blood samples in the parent study.
The Clinical Application of MCCES in Examination of Human Colon

This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the Western world. The screening tests include flexible sigmoidoscopy, optical colonoscopy (OC), double-contrast barium enema , or CT colonography . Such screening can reduce CRC incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .Colon capsule endoscopy(CCE) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by Chongqing Jinshan Science \& Technology. While Screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. However, there's little data report on this colon capsule robot system in clinical application. The investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
* Patients who volunteer to the colonoscopy screening.

Exclusion Criteria:

* Dysphagia or swallowing disorder,
* Congestive heart failure,
* Renal insufficiency,
* Prior major abdominal surgery of the gastrointestinal tract,
* Known or suspected bowel obstruction,
* Presence of a cardiac pacemaker or other implanted electromedical devices,
* Allergy or contraindication to the medications used in the study.
CTP Imaging of Lung Cancer

Investigators hope to learn more about how to use computed tomography (CT) scans to measure blood flow in lung tumors and how it may change in response to treatment. This measurement technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce 3-dimensional images of the body.

Currently, doctors determine the response to treatment by measuring the size of the tumor. Investigators are trying to find out if measuring the blood flow in the tumor is equal to or better than measuring the size of the tumor.

This is an experimental study of CT perfusion (CTP) imaging in subjects with non-small cell lung cancer. The objectives of this study are to demonstrate the feasibility of CT blood flow measurements in lung cancer, to develop a foundation for the use of CT blood flow measurements in lung cancer to assess the response to treatment, and to develop an optimized CTP imaging protocol for evaluating blood flow in solid body tumors. In this study, tumor blood flow will be evaluated at baseline and follow-up routine CT examinations of patients with non-small cell lung cancer, and the response of tumor blood flow will be recorded as a secondary endpoint. This research study will entail two study visits - one required and one optional - which will coincide with regularly scheduled standard of care CT scans.

Eligibility Criteria:
Inclusion Criteria:

adult patients with non small cell lung cancer who receive, or are considered for, systemic therapy

Exclusion Criteria:

renal failure pregnancy known contrast allergy

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Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial

To investigate the efficacy of oral midazolam for patients undergoing rigid cystoscopy in:

1. relieving patient's anxiety and improving satisfaction
2. reducing procedure-related pain
3. facilitating the diagnostic and therapeutic interventions during rigid cystoscopy


Eligibility Criteria:
Inclusion Criteria:

* Elective rigid cystoscopy
* Either diagnostic or therapeutic
* Age between 18 to 80

Exclusion Criteria:

* Patients with allergy to midazolam or other benzodiazepine groups
* Pregnancy
* Emergency rigid cystoscopy
* ASA class 3 or above
* Patients on psychiatric medications
* Alcoholics
Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress

"The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Through confirmation of different profile of BAs in T2DM, investigator will suggest modulation of specific bile acids as a new possible treatment target in patients with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before hyperglycemia.

In addition, investigator will evaluate the association between each BA species and serum total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration in serum. Investigatr also evaluates the correlation between each BA species and metabolic profiles and oxidative stress marker to find possible roles of each BA component in glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

1. pre-diabetes 1. defined according to the ADA guideline (prediabetes definition) FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) or 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) or A1C 5.7-6.4% (39-46 mmol/mol)
2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) FPG ≥126 mg/dL (7.0 mmol/L) or 2-h PG ≥200 mg/dL (11.1 mmol/L) in the 75-g OGTT or A1C ≥6.5% (48 mmol/mol) or In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L) or 2. taking any anti-diabetic medications
3. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI \<25kg/m2

Exclusion Criteria:

1. subjects who refused to agree with informed consents
2. subjects with organ-transplantation
3. pregnant women
4. type 1 diabetes -
Effects of Regional Anesthesia Following Mastectomy

Patients of breast surgery dated between April 2016 and March 2021 will be scanned in three groups; solely induced general anesthesia, general anesthesia induced with Erector Spinae Plane Block, and general anesthesia induced with Rhomboid Block.

The investigators aimed to retrospectively compare the effectiveness of regional anesthesia techniques used in the clinic for postoperative recovery and opioid consumption in patients who underwent breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent breast surgery under general anesthesia with or without one of the blocks; Erector Spinae Plane Block and Rhomboid Block.

Exclusion Criteria:

* Incomplete patient forms.
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam

Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported.

Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam.

The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.


Eligibility Criteria:
Inclusion Criteria:

* children undergoing CT scanning for TBI

Exclusion Criteria:

* epistaxis
* suspected or confirmed skull or nasal fracture
* Moderate to severe traumatic brain injury
* hemodynamically unstable
Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection.
* Oral temperature measurement from 100 to 104 degrees Fahrenheit.
* Onset of fever 3 days or less.
* Otherwise good health.

Exclusion Criteria:

* Fever secondary to a chronic underlying medical condition or serious infection.
* Currently taking antibiotics or antivirals.
* Currently taking any medication which may interfere with the assessment of fever.
* Pregnancy or breast-feeding.
* Any serious medical or psychiatric disorder.