louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01955824: A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy
Official title: "A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lung Cancer
Tuberculosis
Sarcoidosis
Interstitial Lung Disease
Keywords: bronchoscopy
lignocaine
cough
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2013-10-08
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Commonly used topical anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%), tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort. However, the optimal dosage and strength of topical lignocaine that should be used during fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing flexible bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing flexible bronchoscopy
* Hemodynamic stability

Exclusion Criteria:

* Patients receiving sedatives during the course of their treatment
* Patients undergoing conventional TBNA and/or EBUS-TBNA who are likely to receive sedation
* Patients with known hypersensitivity to lignocaine
* Not willing to provide informed consent

Primary outcomes:
measure: Cough suppression (by Operator and Patient)
timeFrame: 15 minutes
measure: Pain control
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Bronchoscopy suite, PGIMER
Study officials:
References:
citation: Kaur H, Dhooria S, Aggarwal AN, Gupta D, Behera D, Agarwal R. A Randomized Trial of 1% vs 2% Lignocaine by the Spray-as-You-Go Technique for Topical Anesthesia During Flexible Bronchoscopy. Chest. 2015 Sep;148(3):739-745. doi: 10.1378/chest.15-0022.
Clinical trial NCT01923324: Standard Telephone Consultation for Pain
Official title: Physician to Physician Telephone Consultation for Chronic Pain Patients: a Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether pain control for patients with chronic pain is improved by the availability of structured telephone consultations between the patients' family physicians and pain physicians, compared to pain control for patients receiving usual care.


Eligibility criteria: Inclusion Criteria:

* patients referred to Alberta Health Services chronic pain center in Calgary with neurological or muscular skeletal pain

Exclusion Criteria:

* increased risk for suicide, very complex patients, family physician could not reliably identify patient's pain problem, or condition warranted expedited consultation with pain physician, case represented a new presentation of chronic regional pain syndrome, or low back pain with radicular symptoms or sciatica

Primary outcomes:
measure: Numerical Rating Scale for pain intensity (NRS)
timeFrame: 6 months
Secondary outcomes:
measure: Pain Disability Index (PDI)
timeFrame: 6 months
measure: Patient Global Impression of Change Scale (PGIC)
timeFrame: 6 months
measure: Short Form Health Survey (SF-36)
timeFrame: 6 months
Other outcomes:
measure: Pain treatment satisfaction scale (patient)
timeFrame: 6 months
measure: Family physician satisfaction questionnaire
timeFrame: 6 months
measure: Family physician knowledge transfer questionnaire
timeFrame: 6 months
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services Chronic Pain Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Neil Drummond, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02590224: The Effect of Iron Deficiency Anemia During Pregnancy
Official title: Ferrous Bis-glycinate Versus Ferrous Glycine Sulfate for the Treatment of Iron Deficiency Anemia During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations.

Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication.

Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.


Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy.
2. Gestational age 14-18 weeks.
3. Mild to moderate anemia
4. No associated medical or obstetric complications.
5. Women not already receiving iron therapy.
6. Women accepted to participate in the study.

Exclusion Criteria:

1. Multiple pregnancy
2. Severe anemia
3. Iron hypersensitivity.
4. Liver diseases.
5. Women refuse to participate in the study.

Primary outcomes:
measure: the rate of increase of Hemoglobin level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT03662724: Venetoclax Registry
Official title: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax: The Venetoclax Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Relapsed/refractory adult acute myeloid leukemia (AML)
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiens with relapsed/refractory AML including patients who received stem cell transplantation.

Brief summary: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax

Detailed description: The aim of this study is to document all patients with AML who are treated with the BCL2 inhibitor Venetoclax outside a clinical trial in all hospitals participating in this registry study in a standardised manner. Data is collected retrospectively and multi-centric. It is neither a therapy study nor is the therapy influenced by this study.

1. Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
2. Collection and integrative analysis of clinical data of included patients.
3. Mutation analysis of available patient samples and correlation with clinical parameters.

Eligibility criteria: Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

-

Primary outcomes:
measure: Overall response rate of Venetoclax treatment.
timeFrame: 4 months
Secondary outcomes:
measure: Event-free survival during Venetoclax treatment
timeFrame: 5 years
measure: Relapse-free survival during Venetoclax treatment
timeFrame: 5 years
measure: Overall survival during Venetoclax treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
state: Niedersachsen
Study officials:
affiliation: Hannover Medical School
name: Michael Heuser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Rabia Shahswar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Gernot Beutel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05520424: An Exploratory Investigation of a Supplement to Promote Brain Health
Official title: An Exploratory Investigation of a Supplement to Promote Brain Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Deficits
Cognitive Change
Stress
Keywords: Focus
Memory
Attention
Stress
Lead sponsor: Parable
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall well-being.


Eligibility criteria: Inclusion Criteria:

* In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Anyone currently taking other supplements
* Anyone with a known allergic reaction
* Previous head trauma
* Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer.
* Any psychological, mental, or neurodevelopmental disorders
* Consumes nicotine or marijuana in any form
* Previous or current alcohol addiction
* Consume more than 10 drinks per week

Primary outcomes:
measure: Perceived changes in mental health symptoms as measured by Questionnaires
timeFrame: 31 days
measure: Perceived changes in stress management as measured by Questionnaires
timeFrame: 31 days
Secondary outcomes:
measure: Changes in Cognitive Functioning
timeFrame: 31 days
Other outcomes:
measure: Changes in plasma/serum biomarkers associated with brain health
timeFrame: 31 days
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058534: Multiperfusion Neonatal System
Official title: Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 640
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born between November 30, 2018 and December 31, 2022, at a gestational age below 33 weeks, and hospitalized in the Neonatal unit of Croix-Rousse hospital

Brief summary: Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter.

In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs.

Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.


Eligibility criteria: Inclusion Criteria:

* Born between November 30, 2018 and December 31, 2022,
* Gestational age below 33 weeks

Exclusion Criteria:

* Severe malformation and / or disease requiring heavy surgical management in the neonatal period
* Admitted at croix rousse hospital after the third day of life

Primary outcomes:
measure: Occurence of infection
timeFrame: through study completion, an average of 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civil de Lyon
state: Rhone Alpes
Study officials:
References:
Clinical trial NCT00654134: Inhalation of 20,000 Endotoxin Units(EU) of Clinical Center Reference Endotoxin in Healthy Volunteers
Official title: Inhalation of 20,000 EU of Clinical Center Reference Endotoxin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2008-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers. Preferably these subjects will have participated in ozone exposure studies, allowing a direct comparison of their responses to both endotoxin and ozone. Additionally, cardiovascular endpoints will be investigated with the CCRE exposure.


Eligibility criteria: Inclusion Criteria:

* Prior participation in Ozone Study
* Healthy adults
* Nonsmokers
* No chronic illness
* No active allergies

Exclusion Criteria:

* Reduced Lung function
* Asthma

Primary outcomes:
measure: To determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers.
timeFrame: 6 hours post challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Us Epa Hsf
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Michelle Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00160134: Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Parallel Group, Single Dose Study to Evaluate Cardiac Hemodynamics and Safety During Right Heart Catheterization of Three IV Doses of SLV320 in Subjects With Congestive Heart Failure Requiring Diuretic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: congestive heart failure, adenosine receptor blocker, cardiac hemodynamic
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized, placebo controlled, multi-center, single dose study to evaluate cardiac hemodynamics and safety of iv SLV320 in 110 subjects with congestive heart failure requiring diuretic treatment. Each subject will receive one dose of SLV320 or placebo or furosemide. The study consists of three visits (or study days when in-subjects are included). Ambulatory subjects will be in hospital for two nights and one day.


Eligibility criteria: Inclusion Criteria:

* history of chronic, symptomatic, mild to severe (NYHA Class II-IV) CHF for at least three months requiring treatment with diuretics and with documented systolic dysfunction
* on stable doses of their individually optimized medication regimen for at least one week prior to enrollment

Exclusion Criteria:

* required hospitalization (for cardiovascular disease) or adjustment of background medications for CHF
* orthostatic hypotension or symptomatic orthostasis
* sitting systolic or diastolic blood pressure \< 90 mmHg
* 2nd or 3rd degree atrio-ventricular block or sick sinus syndrome
* heart rate of \< 50 or \> 110 bpm on the ECG
* transplanted heart
* heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease
* hemodynamically significant left ventricular outflow tract obstruction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Mitrovic V, Seferovic P, Dodic S, Krotin M, Neskovic A, Dickstein K, de Voogd H, Bocker C, Ziegler D, Godes M, Nakov R, Essers H, Verboom C, Hocher B. Cardio-renal effects of the A1 adenosine receptor antagonist SLV320 in patients with heart failure. Circ Heart Fail. 2009 Nov;2(6):523-31. doi: 10.1161/CIRCHEARTFAILURE.108.798389. Epub 2009 Sep 24.
Clinical trial NCT01253434: E2022 Patch Formulation Single Dose Phase I Study
Official title: E2022 Patch Formulation Single Dose Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Japanese Healthy Male Adult Volunteers
Keywords: Transdermal Administration
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.

Detailed description: This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.

Eligibility criteria: Inclusion Criteria

1. Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}
2. Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
3. Subjects who are willing to and can comply with the conditions described in the study protocol.

Exclusion Criteria

1. Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
2. Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.
3. Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
4. Subjects who have excessive skin hair around the region to put the patch on.
5. Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.

Primary outcomes:
measure: Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kagoshima
country: Japan
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Tomoo Ogawa
role: STUDY_DIRECTOR
References: