louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00171119: A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril
Official title: A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Diabetic Nephropathy
Keywords: HYPERTENSION
DIABETES MELLITUS TYPE II
VALSARTAN
BENAZAPRIL
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 81
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
* patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
* patients who give written, signed, informed consent.
* patients with/without mild /moderate hypertension.
* patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
* patients without any accompanying systemic disease

Exclusion Criteria:

* pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
* patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in urine albumin excretion rate after 24 weeks
Secondary outcomes:
measure: Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry
measure: Percent of patients returning to normal urine albumin excretion rate after 24 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02009319: Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients
Official title: Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: endobronchial ultrasound
EBUS - TBNA
elastography
strain ratio
lung cancer staging
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan

Brief summary: The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Detailed description: Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

Eligibility criteria: Inclusion Criteria:

* enlarged discrete N2/N3 lymph nodes
* central tumor with normal mediastinal lymph nodes
* enlarged N1 lymph nodes with normal mediastinal lymph nodes

Exclusion Criteria:

* metastatic disease
* severe co-morbidity that disqualified surgical treatment
* mediastinal infiltration by tumor
* small peripheral lung tumor with normal-sized mediastinal lymph nodes

Primary outcomes:
measure: elastography strain ratio
timeFrame: up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic of Pulmonary and Allergic Diseases Golnik
Study officials:
References:
Clinical trial NCT00800319: ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
Official title: ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Keywords: Alcohol dependence
Opioid antagonist
RDC-0313
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.

Detailed description: This is a single-center, randomized, double-blind, ascending dose, placebo controlled study. Dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. They will be discharged from the facility after the 36-hour postdose assessments are completed.

Eligibility criteria: Inclusion Criteria:

* 18 - 65 years of age
* Body mass index of 19-30 kg/m2 at screening
* If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
* If subject is male, he must agree to reduce the risk of a female partner becoming pregnant

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinically significant medical condition or observed abnormalities
* Clinically significant illness within 30 days of the first study drug administration
* History of opioid dependence
* Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
* Positive resolut for any serology test performed at screening
* Use of alcohol-, caffeine-, or xanthine-containing products
* Tobacco use within 90 days before the first study drug administration
* Participation in a clinical trial within 30 days before screening
* Requirement of a special diet other than vegetarian, or significant food allergy or intolerance

Primary outcomes:
measure: Maximum plasma concentrations (Cmax) of RDC-0313
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinically significant abnormal laboratory findings
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles Phase One Services
state: Kansas
Study officials:
affiliation: Quintiles Phase One Services
name: Philip T. Leese, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turncliff R, DiPetrillo L, Silverman B, Ehrich E. Single- and multiple-dose pharmacokinetics of samidorphan, a novel opioid antagonist, in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):338-48. doi: 10.1016/j.clinthera.2014.10.001. Epub 2014 Oct 29.
Clinical trial NCT02414919: Duration of Use of Highly Effective Reversible Contraception
Official title: Real-world Duration of Use for Highly Effective Reversible Contraception (HERC): A Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: University of Utah
First posted: 2015-04-13
Enrollment: 13880
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who had an IUD or contraceptive implant inserted at the University of Utah healthcare system

Brief summary: To assess the proportion of women who use HERC for ≥2 years of duration


Eligibility criteria: Inclusion Criteria:

-Women who had an IUD or contraceptive implant inserted and removed within the University of Utah from January 1, 2004 to October 31, 2012

Primary outcomes:
measure: Proportion of women who use HERC
timeFrame: 2 years post-HERC initiation
Secondary outcomes:
measure: Duration of real world use of three different HERC devices
timeFrame: 2 years post-HERC initiation
Other outcomes:
measure: Difference in patient characteristics of women who chose different HERC devices
timeFrame: 2 years post-HERC initiation
measure: Proportion of HERC used for ≥3 years of duration
timeFrame: ≥3 years post-HERC initiation
measure: Model the predictors of ≥3 years of duration
timeFrame: ≥3 years post-HERC initiation
Locations:
city: Salt Lake
country: United States
state: Utah
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Sanders J, Turok D, Gawron L, Law A, Wen L, Lynen R. Continuation of Long-Acting Reversible Contraception at Two Years in a University Healthcare Setting: A Retrospective Review. JMCP 2016;22(4a):S126
citation: Sanders JN, Turok DK, Gawron LM, Law A, Wen L, Lynen R. Two-year continuation of intrauterine devices and contraceptive implants in a mixed-payer setting: a retrospective review. Am J Obstet Gynecol. 2017 Jun;216(6):590.e1-590.e8. doi: 10.1016/j.ajog.2017.02.003. Epub 2017 Feb 8.
citation: Sanders J, Turok D, Gawron L, Law A, Wen L, Lynen R. Three-Year Continuation of Long-Acting Reversible Contraceptive methods in a Mixed-Payer Health Care Setting: A Retrospective Review. Contraception 2016;94:405-406.
Clinical trial NCT04492319: Addition of Neostigmine to Levobupivacaine
Official title: The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in Testicular Sperm Extraction Surgery:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spermatic Cord Block
Keywords: Spermatic Cord Block
Neostigmine
Levobupivacaine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 112
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as neostigmine.


Eligibility criteria: Inclusion Criteria:

* Patients aged from 20 to 45 years.
* American Society of Anesthesiologists I-II.
* Undergoing Testicular Sperm Extraction Surgery.
* BMI from 18.5 to 40 kg/m2

Exclusion Criteria:

* Patient refusal
* Contraindications to regional anesthesia (bleeding disorders e.g. international normalized ratio \>1.5, Prothrombin Concentration \<70%, platelet count\<100 × 109, use of any anti-coagulants, local infection, etc.).
* Known allergy to local anesthetics.
* ASA III-IV.
* Patients aged less than 18 or more than 60.
* Body mass index \>35.:

Primary outcomes:
measure: Time from end of surgery to the first postoperative analgesic request
timeFrame: UP TO 24 HOURE
Secondary outcomes:
measure: visual analog scale
timeFrame: UP TO 24 HOURE
measure: spermatic cord block time
timeFrame: UP TO 1 HOURE
measure: Incidence of complications
timeFrame: up to 24 hours
measure: Postoperative analgesic use
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University.
Study officials:
affiliation: lecture
name: Amr wahdan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198119: Excision Limits of Oral Cavity Tumor by Narrow Band Imaging
Official title: Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Keywords: oral cavity tumor
narrow band imaging
subclinical cancer lesion
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.


Eligibility criteria: Inclusion Criteria:

* Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
* No previous surgery for this cancer
* Age \> 18 years
* Patient affiliated to health insurance
* Consent signed by the patient

Exclusion Criteria:

* Metastatic or recurrent disease
* Health care impossibilities for geographic, social, psychic reasons

Primary outcomes:
measure: Reliability for detection of subclinical lesions
timeFrame: baseline
Secondary outcomes:
measure: Excision limits quality criteria
timeFrame: baseline
measure: Detection of suspect lesions
timeFrame: baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Sophie EL BEDOUI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03989219: Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule
Official title: Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule, Solitary
Keywords: cfDNA methylation
CT follow-up
plasma
pulmonary nodule
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 401
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this study are those who meet the inclusion and exclusion criteria.

Brief summary: Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.

Detailed description: This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.

Eligibility criteria: Inclusion Criteria:

* 1. Inclusion criteria:

  1. Aged 40-80;
  2. Lung nodules were detected by CT (≥5mm，≤3cm);
  3. Patients fully understand the informed consent and can sign the informed consent in person.

Exclusion Criteria:

* 2. Exclusion criteria:

  1. Patients diagnosed with malignant tumors in the past;
  2. This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
  3. Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
  4. Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
  5. The researchers concluded that there were other conditions that made it inappropriate to participate in this study

Primary outcomes:
measure: The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956319: A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
Official title: A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Initiation and Maintenance Disorders
Primary Insomnia
Keywords: Insomnia
Zolpidem
Estazolam
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
* Written informed consent has been obtained

Exclusion Criteria:

* Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
* Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
* Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
* Patients who are pregnant, lactating or intend to become pregnant during the study period
* Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
* Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
* Participation in any clinical trial within 1 month prior to randomization

Primary outcomes:
measure: Total score of Pittsburgh Sleep Quality Index (PSQ)
timeFrame: 3 weeks
Secondary outcomes:
measure: Physician's clinical global impression (CGI)
timeFrame: 3 weeks
measure: Patient's global impression (PG)
timeFrame: 3 weeks
measure: Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary
timeFrame: 3 weeks
measure: Incidence and severity of adverse events, including abnormal sleep behavior
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03040219: Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
Official title: Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Malnurtrition
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Folic acid as a appetizer in primary malnutrition


Eligibility criteria: Inclusion Criteria:

Primary malnourished children

Exclusion Criteria:

* previous folic supplementation in the past 3 months

Primary outcomes:
measure: Appetite
timeFrame: Through study completion_ after 3 months from start of supplementation
Secondary outcomes:
measure: Leptin and ghrelin hormone
timeFrame: 3 months
Other outcomes:
measure: Growth
timeFrame: Through study completion -after 3 months from start of supplementation
Locations:
city: Cairo
country: Egypt
facility: Marian girgis
Study officials:
affiliation: Ain Shams University
name: Marian Girgis
role: PRINCIPAL_INVESTIGATOR
References: