louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01952704: Aerobic Exercise to Improve Memory in TBI
Official title: A Randomized Controlled Trial of Aerobic Exercise to Improve Memory in TBI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Brain Injury Research
First posted: 2013-09-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's primary memory center. Only two studies have been conducted in humans, one in healthy elders, and the other in a schizophrenia population. So far, there has never been an aerobic exercise trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as outcomes of interest. The proposed project is a randomized controlled trial of aerobic exercise in persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic exercise (stationary cycling), versus a control condition of non-aerobic exercise (stretching), in memory-impaired TBI patients to a) increase hippocampal volume and b) improve memory. Importantly, we also expect benefits of aerobic exercise on the level of brain function. Specifically, we will look at 'functional connectivity,' which refers to how efficiently remote regions of the brain 'talk' to each other. TBI is an ideal population to benefit from aerobic exercise, given the young age at which many individuals sustain TBI, which allows for benefits of aerobic exercise to be maximally realized in a population with sufficient neurofunctional reserve. The expected benefits of aerobic exercise (increased hippocampal volume, improved memory) from this intervention stand to have a meaningful impact on people with TBI, including improved health, productivity, independence, and quality of life. And, unlike current treatments for memory impairment (e.g., pharmacological agents, cognitive rehabilitation), aerobic exercise is a cost-effective, all natural, readily-available treatment for memory problems.


Eligibility criteria: Inclusion Criteria:

* TBI greater than or equal to 1 year
* MRI compatibility
* Right Handed

Exclusion Criteria:

* Reported lower body weakness or use of an assistive device for walking
* History of pulmonary disease, heart disease, vascular disease of the legs, high blood pressure
* History of stroke, other neurological disease/disorder, serious psychiatric illness
* Engaging in more than 30 minutes of aerobic exercise per week
* Current use of steroids, benzodiazepines, and/or neuroleptics
* History of substance abuse

Primary outcomes:
measure: Hippocampal volume
timeFrame: 1 week post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06325904: Uniportal VATS Versus Chest Tube for Early Empyema
Official title: Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empyema, Pleural
Keywords: Video-assisted thoracoscopic surgery
Pleura
Empyema
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 70
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: This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed to have empyema and indicated for surgery.
* Age above 18 years old

Exclusion Criteria:

* Inability to tolerate single lung ventilation.
* Contraindication for general anesthesia/ medically unfit

Primary outcomes:
measure: Need for further management
timeFrame: 6 months after inital treatment
measure: Mortality
timeFrame: 6 months after inital treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
affiliation: Minia University
name: Mostafa M Elsayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01467804: Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder
Official title: Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Keywords: efficacy,
safety,
JWXYJN
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind multi centric clinic study. Both of therapist and patient are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for major depressive disorder, the score of HAMD-item\>20，\<35；and meet the criteria for TCM syndrome of "Liver Qi stagnation and Transformation of Stagnant Qi into Fire". Patients are randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50 mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN plus placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are measured with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are assessed at baseline and end of program. Then data will be analyzed with SPSS software to determine the efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild to moderate major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older.
* A diagnosis of MDD, single episode or recurrent, according to DSM-IV
* Meets DSM-IV criteria for Major Depressive Disorder.
* factor score from the 24-item Hamilton Depression Rating Scale (HAM-D) \>20,\<35
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
* Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
* Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
* Patients who meet criteria for any of the following DSM-IV MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern \[d\] with Psychotic Features.
* Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.

Primary outcomes:
measure: HAMD scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Academy of Chinese Medicine Science
state: Beijing
Study officials:
References:
Clinical trial NCT00719004: Sonographic Features of Normal Soft Tissues of the Feet
Official title: Sonographic Features of Normal Soft Tissues of the Feet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Disease
Healthy
Keywords: Anatomy
Foot
Sonography
Medical
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers.

Detailed description: To study normal sonographic anatomy of soft tissues of the foot \[which include Extensor retinaculum, sinus tarsi, ligaments and tendons, spring ligament and their attachments to underlying bones\] in asymptomatic individuals/volunteers.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* no disease or abnormality of the feet

Exclusion Criteria:

* abnormality of the feet

Primary outcomes:
measure: Clinical relevance of understanding the anatomy will help in early and accurate identification of pathology.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Gandikota Girish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675804: Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD
Official title: A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Lead sponsor: Allameh Tabatabai University
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 34
Sex: MALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (ADHD).

Detailed description: The investigators administered a randomized controlled trial (RCT) through random assignment of ADHD subjects in to three different groups to compare the effects of CACR, immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with ADHD.

Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis
* age between 7 and 12
* IQ \> 85

Exclusion Criteria:

* sever co-morbid disorder
* seizure
* IQ \< 85
* disability
* sever medical condition

Primary outcomes:
measure: Persian software for the continuous performance test [CPT]
timeFrame: 5 months
measure: Persian software for the Tower of London Test [TOL]
timeFrame: 5 months
measure: Forward/Reversed digit span tasks from the WISC-R testing battery.
timeFrame: 5 months
measure: Raven's colored progressive matrices.
timeFrame: 5 months
measure: Span board task from the Lumosity.com online software (Lumosity.com, 2012)
timeFrame: 5 months
measure: SNAP-IV scales
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Counseling and guidence Center of the Department of education of region 9 of Tehran
Study officials:
affiliation: Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran
name: Saeed Azami, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
name: Alireza Moghadas, PhD
role: STUDY_DIRECTOR
affiliation: Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
name: Faramarz Sohrabi, PhD
role: STUDY_DIRECTOR
affiliation: Department of psychology, University of Bojnord, Bojnord, Iran.
name: Morteza Nazifi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03865004: Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
Official title: Paracetamol Plus Morphine in ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Colic
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.


Eligibility criteria: Inclusion Criteria: Renal colic patients -

Exclusion Criteria: Not renal colic patients

-

Primary outcomes:
measure: pain reductions in VAS scores during the 60th and 90th minutes
timeFrame: 60 minutes
Secondary outcomes:
measure: Need for rescue analgesic
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02307604: SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access
Official title: Screening Platform of EORTC for Clinical Trials Access in Brain Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Neoplasms
Keywords: Brain tumor
Biomarkers
Screening
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2014-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically confirmed brain cancer at any stage.

Brief summary: The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:

* Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
* Identify or validate new molecularly defined subgroups of tumors;
* Investigate the prevalence of novel biomarkers to plan future clinical trials;
* Enable exploratory/future research;
* Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;
* Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
* At least three months life expectancy;
* Written informed consent according to ICH/GCP and national/local regulations;
* Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.

Primary outcomes:
measure: Number of patients with brain malignancy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de Lille
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
Study officials:
affiliation: UniversitaetsSpital Zurich - Department of Neurology, Zurich, Switzerland
name: Michael Weller, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02549404: Phase 3 Study of KHK7580
Official title: Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 137
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Personally submitted written voluntary informed consent to participate in the study
* Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
* Intact PTH level of \> 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)

Exclusion Criteria:

* Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
* Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
* Severe heart disease;
* Severe hepatic dysfunction;
* Uncontrolled hypertension and/or diabetes;
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
* Primary hyperparathyroidism;
* Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
timeFrame: Up to 52 weeks
measure: Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
timeFrame: Up to 52 weeks
measure: Mean percent change in intact PTH level from baseline
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Study officials:
References:
Clinical trial NCT00327704: Early Albumin Resuscitation During Septic Shock
Official title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Keywords: Septic Shock
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 794
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: Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.

Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.

Setting: 27 Intensive Care Units (ICU) in France

Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris

Patients: 800 patients could be included during the first 6 hours of their septic shock.

Detailed description: The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.

The albuminemia of all patients is requested before the treatment until Day 4 post treatment.

The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.

The first patient will be in July 2006, the last patient expected is on July 2009.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Septic shock \< 6 hours
* Agreement of patients

Exclusion Criteria:

* Allergy to albumin
* Weight \> 120 kg
* Non septic shock
* Burned
* Cirrhosis
* Albumin perfusion 48 hours before randomization
* Pregnant women
* Cardiac dysfunction New York Heart Association (NYHA) 3 or 4
* Patients with therapeutic limitation

Primary outcomes:
measure: Mortality, any cause, during the 28 day period after randomization
timeFrame: day 28
Secondary outcomes:
measure: Evaluation of sequential organ failure assessment (SOFA) score
timeFrame: ICU period
measure: catecholamine free days
timeFrame: day 28
measure: incidence of nosocomial infection
timeFrame: ICU period
measure: mortality at 90 days
timeFrame: day 90
measure: length of ICU hospitalisation
timeFrame: ICU discharge
measure: length of total hospitalisation
timeFrame: hospital discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Cochin Hospital
name: Jean P Mira, Professor
role: STUDY_CHAIR
affiliation: Hôpital Cochin
name: Julien Charpentier, Doctor
role: STUDY_DIRECTOR
References: