louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00635713: Second Line Breast Cancer Trial
Official title: A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Breast Cancer
Keywords: Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 588
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women with confirmation of breast cancer
* objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion Criteria:

* presence of life-threatening metastatic visceral disease
* previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
* more than 1 prior endocrine medical treatment for advanced breast cancer .

Primary outcomes:
measure: time to tumor progression
timeFrame: Every 3 months
Secondary outcomes:
measure: objective tumor response
timeFrame: Every 3 months
measure: time to treatment failure
timeFrame: Every 3 months
measure: time to death
timeFrame: Every 3 months
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Guido Hoctin-Boes
role: STUDY_DIRECTOR
References:
Clinical trial NCT02197013: Evaluation of Introcan Safety 3 Closed IV Catheter
Official title: Evaluation of Introcan Safety 3 Closed IV Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients in Need for Intravenous Access
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 200
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: Patients in need for intravenous access

Brief summary: Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety


Eligibility criteria: Inclusion Criteria:

* need for intravenous access

Exclusion Criteria:

* n. a.

Primary outcomes:
measure: Frequency and time of occurence of blood leakage
timeFrame: Within one minute
Secondary outcomes:
measure: Problems during catheter insertion and fixation of Introcan Safety 3
timeFrame: During insertion and fixation of catheter
measure: Necessity of disconnection of catheter
timeFrame: During catheter placement
Other outcomes:
Locations:
city: Dorsten
country: Germany
facility: KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH (KKRN)
Study officials:
affiliation: KKRN
name: Gertrud Haeseler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000213: IV Cocaine Abuse: A Laboratory Model - 2
Official title: IV Cocaine Abuse: A Laboratory Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: intravenous abuse
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Columbia University
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Direct cocaine effects
measure: Interaction of cocaine/fluox. on cardio measures
measure: Interaction of cocaine/fluox. on coc's subjective
measure: Effects of fluoxetine on cocaine craving
measure: Drug use during outpatient fluoxetine maintenance
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Richard Foltin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927713: Hand Jing-Well Points Stimulation to Treat Disorders of Consciousness
Official title: A Multi-center Randomised Controlled Trial to Explore the Ideal Stimulation Strategies at Hand Twelve Jing-Well Points in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disorders of Consciousness Due to Severe Brain Injury
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.


Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years old
* From 7 to 90 days since brain injury
* Diagnosed in VS/UWS or MCS as deﬁned by at least two CRS-R assessments performed during the screening period
* Acquired cerebral damage of known etiology
* Intact hand skin
* Informed consent given by the legal surrogate

Exclusion Criteria:

* Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
* History of previous serious、progressive neurological disorder prior to the brian injury
* Epilepsy and seizure
* Unstable vital signs or life-threatening comorbidities
* Active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc)
* Documented pregnancy

Primary outcomes:
measure: Coma Recovery Scale-Revised (CRS-R) change
timeFrame: baseline, immediately after the end of the 5-day treatment
Secondary outcomes:
measure: ABCD model change
timeFrame: baseline, immediately after the end of the 5-day treatment
measure: ABCD model change
timeFrame: baseline, immediately after the end of the first treatment
measure: Coma Recovery Scale-Revised (CRS-R) change
timeFrame: baseline, immediately after the end of the first treatment
measure: Glasgow Outcome Scale-Extended (GOSE)
timeFrame: at six months post enrollment
measure: Consciousness level change
timeFrame: baseline, at six months post enrollment
measure: Correlation between EEG responsiveness and long-term outcomes
timeFrame: on the first day, the fifth day and at six months post enrollment
measure: Incidence of Adverse Events
timeFrame: from the first treatment to the end of the fifth treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT01090713: Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder
Official title: Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Binge Eating Disorder
Lead sponsor: Lindner Center of HOPE
Sponsor class: OTHER
Collaborators: name: Shire
name: University of Cincinnati
First posted: 2010-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder


Eligibility criteria: Inclusion Criteria:

* Patients will meet DSM-IV criteria for BED for at least the last 6 months

Exclusion Criteria:

* Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.)
* Subjects who are displaying clinically significant suicidality or homicidality.
* A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence

Primary outcomes:
measure: frequency of binge eating episode
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Lindner Center of HOPE
state: Ohio
Study officials:
References:
Clinical trial NCT06685913: The Effect of Ketone Esters on Forearm Glucose Metabolism
Official title: The Effect of Ketone Esters on Forearm Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Blood glucose
Ketone monoester
Substrate metabolism
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important tool for treating disease or recovering from exercise. The purpose of this research is to determine if a ketone drink can increase sugar uptake in our muscles. This research will provide new knowledge about the regulation of blood sugar.

Detailed description: Impaired skeletal muscle glucose uptake following a meal ("insulin resistance"), is a primary risk factor for developing type 2 diabetes. We and others have consistently shown that ingesting exogenous ketones can reduce blood glucose concentration. Mechanistically, this must arise through reduced glucose release (i.e. from liver), and/or increased uptake (i.e. into skeletal muscle). Our current MRC-funded work is focussing on ketone-liver interactions in patients with type 2 diabetes. Here we aim to investigate how KE influence skeletal muscle glucose metabolism.

Eligibility criteria: Inclusion Criteria:

* Age 18-40

Exclusion Criteria:

* Any diagnosed metabolic health condition
* Pregnant
* Smoker
* Diagnosed Cardiovascular disease
* Use of medications deemed by research team to affect study outcomes
* Recent history of musculoskeletal injury
* Aged \>40 or \<18
* Allergy to ingredients in the supplement, including ketones, lactose or milk protein

Primary outcomes:
measure: Forearm glucose net balance
timeFrame: 3 hours
Secondary outcomes:
measure: Forearm non-esterified fatty acid net balance
timeFrame: 3 hours
measure: Forearm amino acid net balance
timeFrame: 3 hours
measure: Serum insulin concentrations
timeFrame: 3 hours
measure: Ketone concentration
timeFrame: 3 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Nutritional Physiology Research Unit, University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: George F Pavis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04342013: RCT: The Effect of an Electronic Clinical Decision Support Application on Perioperative Medication Errors.
Official title: Impact of a Novel Electronic Clinical Decision Support Application on Perioperative Medication Errors and Adverse Medication Events: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative Medication Errors
Perioperative Adverse Medication Events
Keywords: medication safety
perioperative
anesthesiology
clinical decision support
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-blinded, parallel-arm clinical trial to assess the incidence of medication errors and adverse medication events with and without the use of an electronic clinical decision support application.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of a novel clinical decision support application on the rate of perioperative medication errors and preventable adverse medication events. The investigators hypothesize that the perioperative clinical decision support application will reduce the incidence of perioperative medication errors and adverse medication events compared to the standard of care.


Eligibility criteria: Inclusion Criteria:

* Anesthesia clinician (anesthesiologists, certified registered nurse anesthetists (CRNAs), student nurse anesthetists, fellows and residents) at Massachusetts General Hospital.

Exclusion Criteria:

* Study staff

Primary outcomes:
measure: Combined incidence of medication errors and adverse medication events in the perioperative setting
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of medication errors the perioperative setting
timeFrame: 6 months
measure: Incidence of adverse medication events in the perioperative setting
timeFrame: 6 months
measure: Preventability of medication errors and adverse medication events
timeFrame: 6 months
measure: Severity of harm (or potential harm) associated with both medication errors and adverse medication events in the perioperative setting
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Karen C Nanji, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016 Jan;124(1):25-34. doi: 10.1097/ALN.0000000000000904.
Clinical trial NCT01939613: Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients
Official title: Colloid Improves Organ Function by Reducing the Elevation of Intra-abdominal Pressure in Resuscitation of Critical Burn Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn
Keywords: fluid resuscitation
burn
colloid,
multiple organ dysfunction
intra-abdominal pressure
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was performed in the Department of Burn Intensive Care of the Tangdu Hospital, an academic hospital of the Fourth Military Medical University of Xi'an. populaitons were extensive burns who admitted to our hospital within 4 h since burn injury.

Brief summary: The present study was to evaluate the effectiveness of colloid compared with crystalloids for fluid resuscitation in critical burn patients with total burn surface area ≥50%.

Detailed description: Extensive burn patients are some of the most challenging critically ill patients who may have multiple-system organ failure with life-threatening complications.Over time, several resuscitation formulae have been proposed to guide burn resuscitation and the best known ones are Parkland and Evans formulae. The main controversy between the two formulae also focuses on whether to infuse the colloid in the first 24 h.Controversy continues and the conflicting results left many clinicians unsure about the effect of colloids on fluid resuscitation in extensive burn patients who suffer higher risk of hypovolaemia, abdominal compartment syndrome (ACS), multiple organs dysfunction and mortality. To address this uncertainty, we conducted a prospective, randomized, controlled clinical trial to compare fluid resuscitation in extensive burns guided by Parkland formulae with TMMU formulae as a modified Evans formula routinely used in China.

Eligibility criteria: Inclusion Criteria:

* burn patients with total burn surface area ≥50% and full thickness burn surface area ≥30%.

Exclusion Criteria:

* age \<18 yrs, time between burn injury and fluid infusion \> 4 h, time arriving at our burn centre \> 6 h, pre-existing medical illnesses compromising the cardiopulmonary reserve or those need for compassionate care only.

Primary outcomes:
measure: Multiple organs function score (MODS) of extensive burns
timeFrame: 48 hours during fluid resuscitation
Secondary outcomes:
measure: Intra-abdominal pressure (IAP) of extensive burns
timeFrame: 48 hours during fluid resuscitation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Burn and Plastic Surgery,Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Department of Burn and Plastic Sugery
name: Xueyong Li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05678413: Role of Paclitaxel in Stricture Urethra
Official title: Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stricture Urethra
Keywords: DVIU, Stricture, Paclitaxel
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cystourethroscopy will be performed using a 22 Fr rigid cystoscope to allow for ureteric catheter 3F/a wire to be passed through the stricture and into the urinary bladder. DVIU will be performed by cold-knife incisions at the 12-, 3-, and 9 o'clock positions through the full thickness of the fibrosis to healthier appearing tissue. A 23 Fr Wolf (Vernon Hills, IL) injection scope and a standard injection needle was used to inject 30 mg/5mL of paclitaxel vial, 1.5 mL will be injected along the length of each incision into healthier appearing tissue for a total of 5 mL.
Primary purpose: TREATMENT

Brief summary: Stricture urethra is a common disease and has various causing factors. The most common performed procedure is direct visual internal urethrotomy (DVIU), but unfortunately has a high recurrence rates. Multiple trial were performed to improve the outcomes of DVIU. Various intralesional injections were used. in this trial we will evaluate intralesional paclitaxel injection following DVIU.


Eligibility criteria: Inclusion Criteria:

* Anterior urethral stricture
* Short strictures (less than 2 cm)
* International Prostate Symptom Score less than 11 and maximum flow rate \< 15 ml per second.
* No previous treatment for stricture disease

Exclusion Criteria:

* Recurrent cases
* Prior pelvic radiation
* Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.

Primary outcomes:
measure: Success of treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Fawzy Salman
Study officials:
References:
Clinical trial NCT00725413: A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)
Official title: A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.


Eligibility criteria: Inclusion Criteria:

* Eligible subjects are healthy premenopausal women requiring a long-term method of contraception, with a body mass index between 18 and 29 kg/m2, who are willing to give voluntary written informed consent. Subjects must have regular cycles with a usual length between 24 and 35 days.

Exclusion Criteria:

* Male
* Postmenopause
* Infertile
* Under 18; Over 40

Primary outcomes:
measure: Pregnancy
timeFrame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.
measure: (Serious) adverse events
timeFrame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.
Secondary outcomes:
measure: Acceptability (satisfaction questionnaire)
timeFrame: Every 3 months, for the entire duration of the trial
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01184313: Acute Lung Injury After Aortic Valve Surgery
Official title: Acute Lung Injury After Aortic Valve Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Injury
Keywords: aortic valve surgery
CPB
lung injury
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elective aortic valve surgery patients in Oulu University hospital

Brief summary: The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery.

Study questions:

* Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree?
* Is there any correlation between oxyhaemodynamic parameters and lung injury degree?
* Is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers?
* Are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?


Eligibility criteria: Inclusion Criteria:

* elective aortic valve surgery patient
* written consent

Exclusion Criteria:

* none

Primary outcomes:
measure: lung injury
timeFrame: within the first 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University hospital
Study officials:
affiliation: Oulu University Hospital
name: Reija Mikkola, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Fausto Biancari, MD, PhD
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Juha Koskenkari, MD
role: STUDY_CHAIR
affiliation: Oulu University Hospital
name: Vesa Pakanen, MD
role: STUDY_CHAIR
affiliation: Oulu University Hospital
name: Tatu Juvonen, prof.
role: STUDY_CHAIR
References: