louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01814410: Interactive Effects of IV Ethanol and IV Nicotine
Official title: A Laboratory Study on the Interactive Effects of IV Ethanol and IV Nicotine on Subjective Effects and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Intravenous Ethanol
Intravenous Nicotine
Interactive effects
cognition
subjective effects
healthy subjects
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2013-03-20
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. The general hypothesis is that nicotine will attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative effects of ethanol.


Eligibility criteria: Inclusion Criteria:

1. Male and female;
2. between the ages of 21 and 50 years;
3. medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories
4. history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence
5. social drinkers no maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for alcohol dependence (abuse will be allowed) will be excluded from the study.

Exclusion Criteria:

1. history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
2. regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
3. current abuse of any recreational or prescription drugs (except alcohol);
4. alcohol naïve.

Primary outcomes:
measure: Biphasic Alcohol Effects Scale (BAES)
timeFrame: 2 minutes
Secondary outcomes:
measure: Visual Analog Scales of Mood States
timeFrame: 1 minute
measure: QSU-Brief
timeFrame: 2 minutes
measure: Digit Symbol Substitution Task
timeFrame: 2 minutes
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven VA Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth Ralevski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05739110: HCC Staging Modified by Tumor Micronecrosis
Official title: Optimizing Hepatocellular Carcinoma Disease Staging Systems by Incorporating Tumor Micronecrosis: A Multi-institutional Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Tumor micronecrosis
BCLC
TNM
Disease staging
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Huizhou Municipal Central Hospital
name: Second Affiliated Hospital of Nanchang University
name: Meng Chao Hepatobiliary Hospital of Fujian Medical University
First posted: 2023-02-22
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study enrolled patients who underwent liver resection from four institutions in China: the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 896), Mengchao Hepatobiliary Hospital of Fujian Medical University (n = 94), the Second Affiliated Hospital of Nanchang University (n = 84), and Huzhou Central Hospital (n = 36).

Brief summary: Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the performance of the staging models by establishing modified new staging models including tumor micronecrosis.


Eligibility criteria: Inclusion Criteria:

* primary and histologically confirmed HCCs
* patients who underwent curative liver resection

Exclusion Criteria:

* simultaneous presence of other tumors
* patients who had received preoperative antitumor therapies
* no available surgical specimens for evaluating micronecrosis status
* gross tumor necrosis and Nscore = 3

Primary outcomes:
measure: Overall survival
timeFrame: from date after liver resection until death or last follow-up, whichever came first, assessed up to 72 months
Secondary outcomes:
measure: Disease-free survival
timeFrame: from date after liver resection until recurrence or last follow-up, whichever came first, assessed up to 72 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00422110: A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
Official title: A Phase IIb/III, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Seletracetam as Adjunctive Treatment in Subjects (≥16 to 70 Years Old) With Refractory Partial Onset Seizures.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Epilepsies, Partial
Keywords: Seletracetam
Epilepsies
Partial
Epilepsy
Focal
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.


Eligibility criteria: Inclusion Criteria:

* Subjects from 16 to 70 years old
* Confirmed diagnosis of focal epilepsy
* Partial seizures uncontrolled while taking 1 or 2 AEDs
* At least 8 partial seizures during the 8-week baseline period

Exclusion Criteria:

* Seizures occurring only in clusters
* Status epilepticus within 1 year
* Progressive CNS disorder
* Other serious or uncontrolled diseases

Primary outcomes:
measure: Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs
Secondary outcomes:
measure: Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: Barbara Bennett, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00344110: Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
Official title: A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, renin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-26
Enrollment: 768
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension


Eligibility criteria: Inclusion Criteria:

* Age: 20 - 75 years old
* Gender: Male or female
* Status: Outpatients
* Mild to moderate essential hypertension

Exclusion Criteria:

* Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
* Patients with msSBP \>==180 mmHg and/or msDBP \>=110 mmHg at Visit 1, 2 or 3
* Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
* Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Secondary outcomes:
measure: Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan
measure: Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg
measure: Control rate; msDBP <90mmHg and msSBP<140mmHg
measure: The pharmacokinetics / pharmacodynamics
measure: Safety and tolerability
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals, Japan
name: Novartis Pharmaceuticals, Japan
role: STUDY_CHAIR
References:
Clinical trial NCT03022110: Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
Official title: Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Pseudocyst
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 106
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 study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.

Detailed description: Inclusion criteria

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion criteria

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders

Eligibility criteria: Inclusion Criteria:

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion Criteria:

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders

Primary outcomes:
measure: Cyst recurrence rate
timeFrame: up to 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: up to 48 hours
measure: Clinical success rate
timeFrame: up to 12 months
measure: Complication rate
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01954446: A Novel Non-interfering Arterial Blood Pressure Monitoring Device
Official title: A Novel Non-interfering Arterial Blood Pressure Monitoring Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Hypotension
Healthy
Lead sponsor: Sense A/S
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this investigation is to validate the performance and safety of the Investigational Device (ID) against a validated and legally cleared device for measuring Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a period of 24 hours against a validated and legally cleared device for Ambulatory Blood Pressure Monitoring (ABPM).

Detailed description: The clinical investigation is conducted as a controlled (subject as own control), prospective, randomised, comparative investigation in a population with a representative spread of BPs to ensure that the ID performs as good as current marketed and approved devices. The study will be conducted in compliance with the International Standard ANSI/AAMI/ISO 81060-2 - Non-invasive sphygmomanometers - Clinical validation of automated measurement type.

This clinical investigation will enrol up to 96 male and female subjects to ensure the recording of 85/35 evaluable datasets in accordance with the ANSI/AAMI/ISO standard \[11\]. All measurements will be paired and falls into 2 categories: Auscultatory measurements as gold standard reference, oscillometric measurements for clinical practise reference and further validation of ambulatory monitoring and pulse shape measurements.

Eligibility criteria: Inclusion Criteria:

* At least 30% of the subjects must be males (n=29)
* At least 30% of the subjects must be female (n=29)
* Age ≥ 18 years old
* Limb size circumference ≥ 17 cm
* Blood pressure distribution:
* At least 25 % of the subjects should be hypertensive
* At least 5 % of the subjects should be hypotensive

Exclusion Criteria:

* Breached skin
* Acknowledged pregnancy
* Pacemaker
* Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
* Implanted metal in upper limb:

  * Elbow prosthesis
  * Shoulder prosthesis
  * Metal screws
  * Bone plates
  * Metal chips
  * Surgical clips
  * Implantable Cardiac Defibrillator (ICD)
  * Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
  * Premature ventricular contractions (PVC)
  * Premature arterial contractions (PAC)
  * Sensitivity or allergy towards adhesives
* Presence of an arterial-venous shunt
* Recent axillary node dissection

Primary outcomes:
measure: Accuracy of measurement
timeFrame: Up to 4 months
Secondary outcomes:
measure: Skin irritation
timeFrame: Up to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Odense University Hospital
name: Michael H Olsen, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568746: Implementation of a qSOFA Score in the Emergency Department
Official title: Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: screening
qSOFA
sepsis
Emergency care unit
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score \<2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.


Eligibility criteria: Inclusion Criteria:

* body temperature below 36 °C or above 38 °C
* require hospitalization

Exclusion Criteria:

* hospital transfer,
* patients with pre hospital care
* language barrier,
* refusal to participate

Primary outcomes:
measure: mortality rate
timeFrame: 28 days
Secondary outcomes:
measure: support time to medical contact
timeFrame: 1 day
measure: support time to initiation of antibiotics
timeFrame: 1 day
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chu Besancon
Study officials:
References:
Clinical trial NCT03652246: Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling
Official title: Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epileptic Encephalopathy of Unindentified Genetic Origin
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in consultation

Brief summary: Congenital epileptic encephalopathies (EE) are predominantly genetic in origin. Their diagnosis is hampered by the large number of genes involved and their low recurrence. Genetic study in routine diagnosis is limited by the existing techniques and the development costs. The routine diagnostic implementation of high throughput sequencing pushes these limits. High throughput exome sequencing (ES) showed superior diagnostic performance in all diagnostic settings studied.

This pilot study is dedicated to evaluating the diagnostic performance of high throughput ES in EE, with an implementation and analysis strategy allowing for a direct transfer to routine diagnostics. This novel approach should improve the diagnostic rate while reducing the diagnostic cost per patient.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epileptic encephalopathy, defined by the clinical association of epilepsy and a significant delay in acquisition
* Family case with recurrence in siblings, suggesting autosomal recessive transmission or X-linked inheritance (with or without parental consanguinity), or sporadic case resulting from inbreeding.
* Lack of etiologic orientation based on clinical examination.
* Normal routine diagnostic genetic examinations including a metabolic check-up, array CGH analysis.
* Brain imaging which does not suggest an acquired cause.

Exclusion Criteria:

* Unavailable parental samples
* Diagnostic orientation from one of the tests mentioned above
* Brain imaging suggesting anoxia sequelae

Primary outcomes:
measure: Number of diagnoses performed with high throughput ES
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT02906046: Weight in Lower Limbs Improves Gait Ataxia of in Machado-Joseph Disease Patients
Official title: Weight in Lower Limbs Improves Gait Ataxia Of in Machado-Joseph Disease Patients: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Machado-Joseph Disease
Keywords: SCA 3
Ataxic Gait
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 20
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: TREATMENT

Brief summary: Few studies evaluated the efficacy of adding weights on the lower limbs in patients with ataxic disorders. There is no current evidence on which would be the most appropriate weight for use in this context. To assess progress and benefits of using this load, gait of symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective of the study is to evaluate the gait with and without different load weights on lower limbs. Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about which weight they prefer for walking.


Eligibility criteria: Inclusion Criteria:

* Patients should have between 18 and 65 years of age and independent gait

Exclusion Criteria:

* Were the need of assistive devices for walking ≤ 10m (such as crutches, wheelchairs and orthotics)
* Item gait of Scale for the Assessment and Rating of Ataxia (SARA)19≥, presence of other neurological disease that affect motor system
* Orthopedic impairments of lower limbs (fractures or surgeries in the past 6 months)
* Difference between the lower limbs greater than 3.0 cm

Primary outcomes:
measure: Gait speed analysis [speed (mt/min) of walking for 10 meters away]
timeFrame: speed (mt/min) of walking for 10 meters away in 1min timeout
Secondary outcomes:
measure: Gait cadence analysis [cadence (steps/min) of walking for 10 meters away]
timeFrame: cadence (steps/min) of walking for 10 meters away in 1min timeout
Other outcomes:
Locations:
Study officials:
References: