louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01048398: Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.
Official title: Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breech Presentation
Pregnancy
Keywords: ceophalic version
breech presentation
pregnancy
remifentanil
paracetamol
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2010-01-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.

OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.

PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.

Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.

Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events


Eligibility criteria: Inclusion Criteria:

* Fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation.
* Informed consent signed by the mother or legal representative in his absence.

Exclusion Criteria:

* Fetal anomalies
* Severe hypertension
* Allergy to drug used in the test
* Amniotic fluid index ≥ 5 cm
* Contraindication for vaginal delivery
* Uterine abnormality and impaired coagulation
* Placenta previa
* Rh sensitization
* Multiple gestation
* Ruptured membranes
* Premature detachment of normally inserted placenta
* The mother greater weight to 85kg

Primary outcomes:
measure: Degree of decrease in pain experienced by patients during the maneuver according to the VAS
timeFrame: 10 minutes
Secondary outcomes:
measure: Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.
timeFrame: 1 day
measure: Number of adverse events and severity
timeFrame: 1 day
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Txagorritxu
state: Alava
Study officials:
affiliation: Basque Health Service
name: Cesar A Valero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Basque Health Service
name: Henar Muñoz, MD
role: STUDY_CHAIR
affiliation: Basque Health Service
name: Amanda Lopez
role: STUDY_CHAIR
affiliation: Basque Health Service
name: Sandra Guerra, MD
role: STUDY_CHAIR
affiliation: Basque Health Service
name: Olga Echebarria, MD
role: STUDY_CHAIR
affiliation: University of Valladolid
name: Alfonso Velasco, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01565798: Efficacy Of Copper To Reduce Acquisition Of Microbes and Healthcare-acquired Infections
Official title: Copper Antimicrobial Research Program: Environmental and Patient Sampling For Indicator Organisms To Determine The Efficacy Of Copper To Reduce Acquisition Of Microbes From The Patient Care Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare-acquired Infection
Keywords: healthcare-acquired infections
colonization
copper-alloy surfaces
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: Ralph H. Johnson VA Medical Center
First posted: 2012-03-29
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality. Commonly touched items in the patient care environment harbor microorganisms that may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a theoretical advantage to conventional cleaning, as disinfection is continuous rather than episodic.

OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care unit (ICU) reduce risk of HAI.

DESIGN: An intention to treat study where patients are sequentially placed into rooms with or without copper-alloy surfaced objects.

SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer center, and a Veteran's Administration Medical Center.

PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study hospital is eligible for placement into a study room if available.

INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.


Eligibility criteria: Inclusion Criteria:

patients 18 years and older requiring admission to an ICU at one of the study sites were eligible

Exclusion Criteria:

* less than 18 years of age or
* pregnant

Primary outcomes:
measure: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.
timeFrame: July 2010 to June 2011 (up to 1 year)
Secondary outcomes:
measure: Microbial burden and risk of HAI
timeFrame: July 2010 to June 2011 (up to 1 year)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael G Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06910098: Impact of Rosuvastatin Doses on LDL Levels, CPK Levels and Aspartate Aminotransferase Levels
Official title: Assessment of Impact of Rosuvastatin Doses on Low Density Lipoprotein Levels, Creatinine Phosphokinase Levels and Aspartate Aminotransferase Levels: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LDL - Low Density Lipoprotein Receptor Disorder
Rosuvastatin
Lead sponsor: Central Park Medical College
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 195
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Particpants were divided into groups based on doses of rosuvastatin and were assessed and for CPK, LDL and AST levels


Eligibility criteria: Inclusion Criteria:

patients who were already on statins

Exclusion Criteria:

hereditary diseases including familial hypercholesterolemia and kidney diseases

Primary outcomes:
measure: impact of rosuvstatin over LDL, CPK and AST levels
timeFrame: 12 weeks
measure: impact of rosuvstatin over LDL, CPK and AST levels
timeFrame: 12 weeks
measure: impact of rosuvstatin over LDL, CPK and AST levels
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Central Park Teaching Hospital
Study officials:
affiliation: Central Park Medical College
name: Sikandar
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Park Medical College & Teaching Hospital
name: Sikandar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04555798: Effect of Arterio-venous ECMO on Severe Sepsis and ARDS
Official title: The Immunoadsorption Effect of Arterio-venous ECMO in Refractory Septic Shock With ARDS Following Severe Lung Contusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Patients With Respiratory Failure and Shocked
Lead sponsor: King Abdul Aziz Specialist Hospital
Sponsor class: NETWORK
Collaborators: name: King Abdul Aziz Specialist Hospital
First posted: 2020-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 patients from those who showed no improvement after 10 days ventilation and still had respiratory failure and in need of high ventilatory parameters (as mentioned before), fulfilled \> 2 parameters on SOFA score as illustrated in table (2), \> 6 on CPIS score as illustrated in table (3) and developed circulatory failure (septic shock) with nor-adrenaline infusion and only on high dose of nor-adrenaline included in our study (\>5microgram/kg/minute intravenous infusion as circulatory support). Since the parameters of those 100 patients selected are considered indication for arteriovenous extracorporeal membranous (A-V ECMO), so patients randomly allocated in two groups 50 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time
Primary purpose: SCREENING

Brief summary: To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion.

Detailed description: 100 patients with respiratory failure without improvement after 10 days ventilation due to development of VAP with ARDS, had \>2 SOFA score and \>6 CPIS score included in two groups 50 patients in each. Only patients of group B put on A-V ECMO while patients of group A continue on traditional way of management. Improvement of ARDS \&VAP, weaning from ventilation, duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores, morbidity and mortality recorded and compared within 14 days.

Eligibility criteria: Inclusion Criteria:

* Those who had an age between 18-65 years old
* patients ventilated for more than 10 days
* with conscious level more than 8/15 on Glasgow Coma Scale

Exclusion Criteria:

pediatric patients below 18 years of age

Primary outcomes:
measure: number of patients weaned from ventilators
timeFrame: 2 weeks
measure: number of patients disharged from ICU
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ta'if
country: Saudi Arabia
facility: King abd el Aziz specialist hospital
Study officials:
References:
Clinical trial NCT05454098: Clifutinib Food Effect Study in Healthy Subjects
Official title: A Food Effect Phase I Study of the Clifutinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia in Children
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects (male or female), age greater than or equal to 18 years and less than or equal to 45 years;
* Weight ≥50 kg (≥45 kg for female), and have a body mass index (BMI) between 18 and 28 (including 18 and 28) at screening;
* Physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator;
* Male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose, and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating；
* Volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures.

Exclusion Criteria:

* Have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
* Unable to tolerate standard meals;
* Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) \>470 ms (female \>480 ms), or history of long QT syndrome；
* Have received live vaccine(s) within 3 months prior to screening;
* Have used over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study;
* Have known allergy to any drug or food;
* Smoking more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) within 3 months prior to screening, or unwilling to abide by smoking restrictions during the study;
* Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody ,human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody;
* Known history of drug abuse

Primary outcomes:
measure: Cmax
timeFrame: 4 weeks
measure: AUC0-∞
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: Through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT00000198: Piracetam for Treatment of Cocaine Addiction - 3
Official title: Piracetam for Treatment of Cocaine Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 21
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 IV cocaine administration in cocaine dependent subjects maintained on piracetam while they are residing in an inpatient addictions treatment research unit and to subsequently follow these patients in an eight week open label assessment of piracetam in an outpatient treatment program.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Pulse, blood pressure
measure: Adverse effects
measure: High, anxiety, withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kyle Kampman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00460798: SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Official title: A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Sunitinib
kidney diseases
urogenital neoplasms
kidney cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 356
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 treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists

Brief summary: This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

Detailed description: The Statistical Analysis Plan provides detailed specification of the analysis

Eligibility criteria: Inclusion Criteria:

* First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

* Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Primary outcomes:
measure: Number of Participants With Categorical Best Overall Response
timeFrame: Start of Treatment up through 12 Months or Early Discontinuation
measure: Number of Participants With Objective Response
timeFrame: 12 Months or Early Discontinuation
measure: Time to Progression (TTP)
timeFrame: Start of Treatment up through 12 Months or Early Discontinuation
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline, 3, 6, 9 and 12 Months
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
timeFrame: Baseline, 3, 6, 9 and 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01339598: Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Disorder
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.


Eligibility criteria: Inclusion Criteria:

* Participants will be right-handed subjects aged 18-65 meeting DSM-IV diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks
* A score of ≤ 20 on the MADRS, and a score of ≤ 6 on the YMRS, who have been on a stable dose of mood stabiliser medications for at least 1 month.

Exclusion Criteria:

* Patients with high suicide risk
* Co-morbid DSM-IV diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder
* Mental retardation
* A history of drug or alcohol abuse or dependence within the last 3 months
* Co-morbid attention deficit hyperactivity disorder (ADHD), or any neurological disorder
* Recent stroke
* Head injury
* History of seizure, or who have had electroconvulsive therapy (ECT) within the 6 months preceding enrolment.
* Participants will also be excluded if currently taking medications known to be associated with frank cognitive impairment (e.g., benzodiazepines).

Primary outcomes:
measure: Total correct responses.
timeFrame: Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of New South Wales
state: New South Wales
Study officials:
References:
Clinical trial NCT03494998: Refining and Testing the Diagnostic Accuracy of PAT-POPS
Official title: Refining and Testing the Diagnostic Accuracy of an Assessment Tool (PAT-POPS) to Predict Admission and Discharge of Children and Young People Who Attend an Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric ALL
Lead sponsor: Pennine Acute Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: University of Salford
name: University of Manchester
First posted: 2018-04-11
Enrollment: 80000
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is designed in such a way that all patients, within the age range, will be enrolled into the study upon arrival at the Emergency Department. Therefore, the study population will be recruited consecutively and data collection has been planned prospectively.

Brief summary: Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is putting pressure on the National Health Service (NHS). Health professionals make complex judgements on whether children attending EDs can be sent home safely or require admission. The Pennine Acute Hospitals (PAT) Paediatric Observation Priority Score (PAT-POPS) was developed as an ED-specific screening tool for this purpose. A preliminary study showed it to be a potentially effective tool for deciding admission of children from the ED. Therefore, the focus of this study is to refine the original screening tool.


Eligibility criteria: Inclusion Criteria:

* Children and young people aged 0-16 years of age who attend the Emergency Department

Exclusion Criteria:

* Patients who are confirmed dead on arrival at the Emergency Department
* Patients who attend the Emergency Department in cardio-respiratory arrest

Primary outcomes:
measure: Admission or discharge
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
city: Oldham
country: United Kingdom
facility: The Royal Oldham Hospital
city: Rochdale
country: United Kingdom
facility: Rochdale Infirmary
Study officials:
References: