louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03858556: Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Official title: Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lumbar Disc Herniation
Gait Analysis
Manual Therapy
Keywords: gait
effectiveness
treatment
Lumbar intervertebral disc herniation
Chuna
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to Jaseng Hospital of Korean Medicine

Brief summary: Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation

Detailed description: To investigate the effect of Chuna manual therapy on gate, 20 patients with lumbar disc herniation were studied. The gait analysis was performed before the first treatment, after the seventh treatment, after the 14th treatment, and compared with the data of 20 normal subjects.

Eligibility criteria: Inclusion Criteria:

* Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
* Patients with radiculopathy
* Patients aged 19 to 60
* Patients with an Oswestry Disability Index (ODI) of ≥10
* Patients who have agreed to participate in the clinical study and given written informed consent

Exclusion Criteria:

* Patients who were unable to walk for more than 5 minutes due to pain
* Patients with a serious disease that may limit gait(such as spinal metastasis of the tumor, acute fracture and spinal dislocation)
* Patients with chronic conditions that may interfere with the interpretation of the therapeutic effect or outcome(such as chronic kidney failure)
* Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
* Patients with severe mental illness
* Patients who are currently on on steroids, immunosuppressants, psychiatric medications, or other medications that can affect outcome
* Patients who are pregnant or planning a pregnancy
* Patients who are participating in other clinical studies or if it is difficult for you to participate in clinical research as determined by the researcher

Primary outcomes:
measure: Gait parameter change
timeFrame: baseline, 2 weeks after baseline
Secondary outcomes:
measure: ODI
timeFrame: baseline, 2 weeks after baseline
measure: EQ-5D
timeFrame: baseline, 2 weeks after baseline
measure: Lumbar ROM
timeFrame: baseline, 2 weeks after baseline
measure: SLR
timeFrame: baseline, 2 weeks after baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00283556: High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
Official title: Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Glioma
Keywords: High Dose Irinotecan
CPT-11
Camptosar
Malignant Glioma
Unresectable
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
First posted: 2006-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Detailed description: This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Eligibility criteria: Inclusion Criteria:

* recurrent, unresectable primary CNS neoplasm per MRI
* ECOG status of 2 or less
* no prior therapy with camptothecans
* on an enzyme-inducing antiepileptic

Primary outcomes:
measure: The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
timeFrame: 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Director
name: Renato V. LaRocca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04413656: cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
Official title: cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: ablation
circulating free DNA
methylation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 90
Sex: ALL
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 objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.

Detailed description: The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.

The main research content is to screen the cfDNA methylation index that can monitor the efficacy of stage I lung cancer ablation and compare the similarities and differences of cfDNA methylation in patients with stage I lung cancer after surgery and ablation.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-85 years old;
2. The peripheral pulmonary nodules found in patients with chest CT, preoperative examination showed that the clinical stage of patients was T1N0M0, IA;
3. patients are not suitable for surgical treatment through multidisciplinary assessment, agree to accept ablation
4. Patients have good compliance with the tests and follow-ups, understand the situation of the study and sign informed consent.

Exclusion Criteria:

1. The patient is generally in poor condition and cannot tolerate the examination;
2. patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the lungs are adjacent to large blood vessels or important structures;
3. patients with poor compliance;
4. Researchers believe that it is not appropriate to participate in this trial.

Primary outcomes:
measure: Screening and monitoring the change of cfDNA methylation index
timeFrame: before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month
Secondary outcomes:
measure: Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation
timeFrame: before surgery , after surgery 1month, 3month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00118456: Study of Oral AEE788 in Adults With Advanced Cancer
Official title: A Phase I/II, Multicenter, Randomized Dose-Escalation Study of Oral AEE788 on Intermittent Dosing Schedules in Adult Patients With Advanced Cancer (Effective Amendment 5) Previously Entitled A Phase IA, Multicenter, Dose-Escalating Study of Oral AEE788 on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Advanced cancers
EGFR
Her2
VEGFR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-11
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed solid tumor
* Adequate hematologic, renal and hepatic function
* Age ≥ 18 years
* Karnofsky performance status score ≥ 70%
* Life expectancy ≥ 12 weeks

Exclusion Criteria:

* Active brain metastases
* Peripheral neuropathy \> grade 2
* Diarrhea \> grade 1
* Gastrointestinal (GI) dysfunction
* Compromised cardiac function
* Concurrent severe and/or uncontrolled medical conditions

Primary outcomes:
measure: Maximum-tolerated dose and dose-limiting toxicity of AEE788
timeFrame: 4.5 years
measure: Maximum-tolerated dose, safety and tolerability of AEE788
timeFrame: 4.5 years
Secondary outcomes:
measure: Single dose and repeated dose pharmacokinetic profile of AEE788
timeFrame: 4.5 years
measure: Pharmacodynamic effects
timeFrame: 4.5 years
measure: Changes in glucose metabolism/cell viability
timeFrame: 4.5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Institute of Drug Development/Cancer Therapy and Research Center
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01593956: Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes
Official title: Influence of Anodal Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussed Athletes
Healthy Controls
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: Concussed athlethes have discrete decreased abilities in motor learning. Recent research could further show, that cortical plasticity, as measured by transcranial magnetic stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what have been found in concussed athletes by paired pulse protocols in TMS.

GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased tDCS.

Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in concussed athlethes.


Eligibility criteria: Inclusion Criteria:

* history of at least 2 sports concussion
* age 18 - 50 years

Exclusion Criteria:

* structural deficit on cerebral MRI
* Epilepsy
* neurological disorder
* intake of CNS-active drugs

Primary outcomes:
measure: Improvement of cortical plasticity after anodal tDCS in concussed athletes
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Department of neurology
Study officials:
affiliation: Charité - Department of Neurology
name: Jonathan List, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité - Department of Neurology
name: Agnes Flöel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Beaumont L, Tremblay S, Poirier J, Lassonde M, Theoret H. Altered bidirectional plasticity and reduced implicit motor learning in concussed athletes. Cereb Cortex. 2012 Jan;22(1):112-21. doi: 10.1093/cercor/bhr096. Epub 2011 May 13.
citation: Stagg CJ, Bachtiar V, Johansen-Berg H. The role of GABA in human motor learning. Curr Biol. 2011 Mar 22;21(6):480-4. doi: 10.1016/j.cub.2011.01.069. Epub 2011 Mar 3.
citation: Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
Clinical trial NCT00751556: Single/Multiple Dose Bioavailability Trial
Official title: An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Naproxen Sodium
Bioavailability
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.


Eligibility criteria: Inclusion Criteria:

* Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight \>50 kg (110Ibs)

Exclusion Criteria:

* History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
* History of gastrointestinal bleeding or perforation related to previous Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment

Primary outcomes:
measure: Pharmacokinetics parameters
timeFrame: Over 48 Hours
Secondary outcomes:
measure: Assess the safety and tolerability of the investigational product
timeFrame: Over 48 Hours
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05175456: Use of a Sleep System to Improve Sleep
Official title: Bed Cooling System to Effect Better Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Fitbit LLC
First posted: 2022-01-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of a bed cooling system on subjective and objective measures of sleep in physicians who work rotating shifts. The intent of the Investigators is to perform a before-and-after trial of a bed cooling system and determine the effects of that cooling system on sleep.

Detailed description: All practicing providers (residents, APPs, and attendings) in the Departments/Divisions of emergency medicine, Ob/Gyn, hospital medicine and family medicine will be offered participation in the study via an email invitation.

Participants will be given a Fitbit device that measures the time of sleep and stages of sleep. Data from the Fitbit are synced to the participant's smart phone. Participants will complete the Single-Quality of Sleep (SQS) scale questionnaire on a daily basis. This questionnaire will be sent to participants on a daily basis via email. This questionnaire is a simple 0-10 rating scale of the quality of their sleep. Participants will then receive the Bedjet cooling sleep system and use it for 10 days to become acclimatized to it. Then they will use the Bedjet for 28 more days, while again completing the daily SQS. This is not a randomized trial, but rather a before-and-after trial.

Changes in mean daily sleep score, SQS from control and intervention time periods will be computed. Subjective measures of participant's satisfaction with the Bedjet system will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Residents, Fellows, Clinical Faculty and Advanced Practice Providers (APPs) of UMass Memorial/UMass Medical School who work rotating shifts or nightshifts in Emergency Medicine, Ob/Gyn, Hospital Medicine, or Family Medicine are eligible to participate (pregnant women are also eligible).

Exclusion Criteria:

-

Primary outcomes:
measure: Sleep Quality Scale change
timeFrame: after 4 weeks
measure: Fitbit Sleep Score
timeFrame: 4 weeks before Bedjet system and the 4 weeks after
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMassMemorial Health Care
state: Massachusetts
Study officials:
References:
Clinical trial NCT04832256: Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels
Official title: Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels: Noninvasive Carbon Monoxide Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fresh Flow
Carboxyhemoglobinemia
Keywords: Low flow anesthesia
Non-invasive carboxyhemoglobinemia monitoring
Smoking
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective surgery

Brief summary: To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level non-invasively and continuous measurement and to determine the contribution of smoking to the intraoperative carbon monoxide accumulation.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Undergo 2-4 hours of elective surgery

Exclusion Criteria:

* Cardiovascular disease
* diabetes mellitus
* kidney, liver failure
* chronic obstructive pulmonary disease
* patients with opioid sensitivity
* morbidly obese
* personal or family history of malignant hyperthermia
* history of prolonged recovery from anesthesia
* alcohol addicted
* pregnant and breastfeeding women patients allergic to study drugs

Primary outcomes:
measure: effects of different fresh gas flows on carboxyhemoglobin levels
timeFrame: during surgery
Secondary outcomes:
measure: effects of smoking on carbon monoxide accumulation.
timeFrame: during surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
citation: Koksal BG, Kucukosman G, Ozcan P, Baytar C, Bollucuoglu K, Okyay RD, Ayoglu H. Effects of different fresh gas flows on carboxyhemoglobin levels: non-invasive carbon monoxide monitoring: A randomized clinical trial. Saudi Med J. 2022 Aug;43(8):891-898. doi: 10.15537/smj.2022.43.8.20220424.
Clinical trial NCT03666156: Adult Weight, Genetics and Lifestyle Factors
Official title: The Influence of Nutrition, Childhood and Adult Lifestyle Factors and Genetic Predisposition on Body Mass Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European Citizen Aged between 18-65 years Female. Caucasian

Brief summary: Childhood obesity leads to adulthood obesity, demonstrated in many retrospective and longitudinal studies. Genetics as a predictor of obesity is less established. Morandi et al, (2012) assessed whether lifestyle and genetic factors can be used to predict childhood obesity, concluding that genetics had minimal predictive effect. More recently Seyednasrollah, (2017) demonstrated that genetic information, when alongside clinical factors for cardiovascular disease, increased the predictive accuracy of obesity risk in adults. This study aims to investigate if known lifestyle and genetic risk factors are associated with BMI and if they can be used as predictors of overweight/obesity in adults.


Eligibility criteria: Inclusion Criteria:

* European Citizen.
* Aged between 18-65 years.
* Female.
* Caucasian

Exclusion Criteria:

* Currently following a diet or weight loss plan or have not been for over 6 months of the previous year.
* Suffering from diabetes (type I or II).
* Cancer, or have had cancer in the past.

Primary outcomes:
measure: Body Mass Index
timeFrame: September - November 2018
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's University
Study officials:
References: