louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03543917: Post-Stroke Improvement of Motor Function
Official title: Post-Stroke Improvement of Motor Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebrovascular Accident
Lead sponsor: Fundatia Bio-Forum
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The new combination treatment is given to all consecutive patients and compared to literature and between groups (based on the time lapsed between CVA and treatment)
Primary purpose: TREATMENT

Brief summary: Open-label clinical study where all new patients presenting with cerebrovascular accidents and consenting to treatment are given intravenously a new combination of medications. Patients are evaluated neurologically with NIHSS scores before treatment administration and at 1 month after the first treatment. Further evaluations at 6 months after treatment by NIHSS and Barthel scores are ongoing

Detailed description: Patients with cerebrovascular accidents (CVA), ischemic (including those with hemorrhagic transformation), are given a new combination of medications which aims to improve neuronal survival, stimulate mitochondrial genesis and the formation of new synapses. This combination is given as an intravenous perfusion with a 2-hr duration and consists of vitamins B1, B6, B12, C, Actovegin, etc.

Before treatment a NIHSS score is given. Each patient receives 3-4 such perfusions in 1 month and afterwards another NIHSS score is obtained.

Patients are monitored afterwards and those who show improvements receive more such treatments, and new NIHSS and Barthel scores are obtained.

Patients are grouped on the basis of the time interval between CVA occurence and first treatment:

* Group 1: 0-35 days
* Group 2: 36-100 days
* Group 3: 101-360 days Improvement of motor function is compared using NIHSS scores between groups, and between literature and groups

Eligibility criteria: Inclusion Criteria:

* adults with CVA
* agreeing to treatment in person or by proxy signing of Informed Consent Form
* available for NIHSS evaluation

Exclusion Criteria:

* allergy to any of the substances administered
* scheduled for surgery or other procedures
* not available for NIHSS evaluation after at least 48 hours from treatment

Primary outcomes:
measure: NIHSS differential
timeFrame: 1 month after first administration of the combination
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Fundatia Bio-Forum
state: Bucuresti
Study officials:
affiliation: Fundatia Bio-Forum
name: Felician Stancioiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02065817: Dose of Labeled Cholesterol for Kinetics: A Pilot Study
Official title: Dose of Labeled Cholesterol and Phenylalanine for HDL Kinetics: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism
Keywords: Lipid
Apolipoproteins
Cardiovascular disease risks
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.


Eligibility criteria: Inclusion Criteria:

• Healthy men and women ages 18 - 50

Exclusion Criteria:

* Cardiovascular disease
* Metabolic disease
* Hematologic disorder
* Liver or kidney disease
* phenylketonuria
* Currently taking lipid lowering medications or any other drugs that could affect lipid metabolism

Primary outcomes:
measure: Incorporation of orally administered 13C3 cholesterol into plasma cholesterol
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John M Miles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319917: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
Official title: FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Tacrolimus
Rheumatoid Arthritis
Tacrolimus anhydrous
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria
* Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine
* Those who have at least one erosion on X-ray of hands, wrists or feet

Exclusion Criteria:

* Those who have been treated with any biologic drugs or leflunomide
* Those who meet Class 4 with the Steinbrocker functional classification

Primary outcomes:
measure: Radiographic progression of structural joint damage
timeFrame: 52 Weeks
Secondary outcomes:
measure: Signs and symptoms of rheumatoid arthritis
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Chyugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Hokuriku region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Shin-etsu region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04946617: Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels
Official title: The Effect of Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mouth and Tooth Diseases
Periodontal Diseases
Gingivitis
Keywords: Periodontitis
Gingivitis
Mouthwashes
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size was calculated using (power of 80%). The present study included 40 patients per group (total of 120) to have a power \>80%.

Brief summary: Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. Therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hBD2 and LL-37 in saliva.

Detailed description: Periodontal health continues with a balanced interaction of the oral microflora with the host defense line.

Eligibility criteria: Inclusion Criteria:

1. systemically healthy,
2. presence of ≥20 natural teeth,
3. agreement to participate in the study .

Exclusion Criteria:

1. known systemic illness,
2. smoking habit,
3. pregnancy/ lactation,
4. long-term use of anti-inflammatory drugs.

Primary outcomes:
measure: Rate of periodontal parametres changes
timeFrame: 6 Months
measure: Rate of periodontal parametres changes
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Medeniyet University
name: Mustafa C Yavuz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Dyke TE. Pro-resolving mediators in the regulation of periodontal disease. Mol Aspects Med. 2017 Dec;58:21-36. doi: 10.1016/j.mam.2017.04.006. Epub 2017 May 18.
Clinical trial NCT02072317: Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer
Official title: Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: PFS
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate and compare safety and effectiveness of Chemotherapy in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer

Detailed description: from the first cycle of treatment (day one) to two month after the last cycle

Eligibility criteria: Inclusion Criteria:

1.18\~75 years old 2.Pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma 3.patient failed after The first line treatment of 5-Fu and platinum ,patient relapse half year after using 5 - Fu and platinum as Postoperative adjuvant chemotherapy 4.ECOG 0-1 5.At least one measurable objective tumor lesions 6.ANC≥1.5\*109/L；PLT≥80\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤1.5ULN； Cr≤ULN；Ccr≥60ml/min 7.Expected survival period for 3 months or more 8. patients with voluntary participation, and sign the informed consent

Exclusion Criteria:

1. Recurrence after transfer have received taxol or docetaxel as first-line chemotherapy,If the adjuvant chemotherapy with paclitaxel,From the last chemotherapy for 6 months or less
2. With uncontrollable large pleural or peritoneal effusion
3. In the near future has a history of myocardial infarction (3 months)
4. Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas;
5. With brain metastasis
6. Severe uncontrolled medical disease or acute infection
7. Pregnancy or breast-feeding women
8. Has a long history of chronic diarrhea, or now complete intestinal obstruction patients

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Since the date of random to disease progression or any cause of death，the average time is 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04258917: Impact of Crutch Type on Gait and Functional Outcomes Post-knee Surgery
Official title: Impact of Crutch Type on Kinematics, Electromyography, Pain, and Comfort Following Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Knee Arthroplasty
Anterior Cruciate Ligament Reconstruction
Keywords: crutches
gait
mobility
adult
knee replacement
ACL tear
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Lethbridge
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study withdrawn

Detailed description: Study withdrawn

Eligibility criteria: Inclusion Criteria:

* Subjects 45-75 years old planning to get their first total knee replacement
* Subjects 18-45 years old planning to get their first anterior cruciate ligament reconstruction

Exclusion Criteria:

* Previous injury to shoulder, elbow, or wrist
* Current pain in shoulder, elbow, or wrist
* Inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis),
* History of cerebral palsy, stroke, significant cognitive impairment, or significant visual impairment
* Problems with the heart or lungs
* Currently using a crutch or crutches, walker, or other gait aid
* History of using a crutch or crutches for 4 or more weeks
* Inability to communicate in English
* Current smoker
* Currently pregnant

Primary outcomes:
measure: Range of scapular downward rotation
timeFrame: Measured during gait assessment on post-operative day 4-12
Secondary outcomes:
measure: Bilateral upper extremity kinematics
timeFrame: Measured during gait assessment on post-operative day 4-12
measure: Bilateral upper extremity electromyographic (EMG) activity
timeFrame: Measured during gait assessment on post-operative day 4-12
measure: Upper extremity pain
timeFrame: Measured at 3 time points: pre-operative, during gait assessment, and 4 weeks post-operative
Other outcomes:
measure: Weight-bearing lower extremity kinematics
timeFrame: Measured during gait assessment on post-operative day 4-12
measure: Torso kinematics
timeFrame: Measured during gait assessment on post-operative day 4-12
measure: Spatiotemporal parameters
timeFrame: Measured during gait assessment on post-operative day 4-12
measure: Crutch comfort
timeFrame: Measured during gait assessment on post-operative day 4-12
measure: Number of falls
timeFrame: Measured at 4 weeks post-operation
Locations:
Study officials:
affiliation: Department of Clinical Neurosciences, University of Calgary
name: Ranita Manocha, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841217: Regulation of Lipoprotein Transport in Metabolic Syndrome
Official title: Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lipid Disorders
Cardiovascular Disease
Keywords: Drug treatment
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
Collaborators: name: National Heart Foundation, Australia
First posted: 2009-02-11
Enrollment: 13
Sex: MALE
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: The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

Detailed description: The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD). Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated. We therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.

Eligibility criteria: Inclusion Criteria:

* Any three of the following:

  * Waist circumference \> 102 cm
  * Triglycerides \> 150 mg/dL
  * HDL-cholesterol \< 40 mg/dL
  * Blood glucose \> 110 mhg/dL
  * Blood pressures \> 130/85 mmHg

Exclusion Criteria:

* Triglycerides \> 500 mg/dL
* Diabetes mellitus
* CVD
* Consumption of \> 30 g alcohol/day
* Use of agents affecting lipid metabolism
* APOE2/E2 genotype
* Creatinemia (\> 120 umol/L)
* Hypothyroidism
* Abnormal liver and muscle enzymes

Primary outcomes:
measure: ApoB transport rate
timeFrame: 5 weeks
Secondary outcomes:
measure: ApoA and C-III transport rate
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Perth
country: Australia
facility: University of Western Australia
state: Western Australia
Study officials:
References:
citation: Ooi EM, Watts GF, Sprecher DL, Chan DC, Barrett PH. Mechanism of action of a peroxisome proliferator-activated receptor (PPAR)-delta agonist on lipoprotein metabolism in dyslipidemic subjects with central obesity. J Clin Endocrinol Metab. 2011 Oct;96(10):E1568-76. doi: 10.1210/jc.2011-1131. Epub 2011 Aug 3.
Clinical trial NCT05031117: Dural Puncture Epidural Technique For Vaginal Procedures
Official title: Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Laparoscopic Assisted Vaginal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Diseases Requiring Vaginal Hysterectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 25G Dural Puncture Epidural Technique will be compared with Conventional Standard Lumbar Epidural Technique During Anesthesia of Laparoscopic Assisted Vaginal Hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Age: 25-55 years old.
* Height: 165 cm.

Exclusion Criteria:

* Patient Refusal.
* Coagulopathy.
* Deformity of lumbar vertebrae.

Primary outcomes:
measure: incidence of bilateral sacral blockade
timeFrame: Up to 30 minutes after local anesthetic injection
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia, Surgical ICU, and Pain Management
Study officials:
References:
Clinical trial NCT06942117: Investigating the Effect of Caffeine Consumption on Speech Understanding in Noise in Young Adults
Official title: Investigating the Effect of Caffeine Consumption on Speech Understanding in Noise in Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Caffeine is a widely consumed substance worldwide and is often used to increase alertness and improve cognitive functions. Caffeine stimulates brain activity by binding to adenosine receptors, which increases alertness instead of sleepiness. Studies on the effects of caffeine on cognitive functions have shown that it improves basic cognitive functions such as attention, reaction time, and alertness, while a less pronounced effect is seen on sensory functions such as vision and hearing. However, no study has been found investigating the effect of caffeine consumption on understanding speech in noise. Understanding speech in noise is a skill that includes not only auditory functions but also cognitive functions. This skill is affected by cognitive elements such as selective attention and executive functions. In this context, it is thought that this study, which aims to examine the relationship between caffeine and understanding speech in noise, will contribute to the literature. 60 participants between the ages of 18-30 will be included in this study. Participants will consist of individuals without hearing loss (SSO\<25 dB nHL), no history of neurological or psychological disorders, non-smokers, and those who do not use ototoxic drugs. Participants will be randomly divided into a placebo group that consumes decaffeinated coffee and a study group that consumes coffee containing 300 mg caffeine. The Turkish Matrix Test will be administered 30 minutes after coffee consumption. In addition, participants will be asked to keep a caffeine diary for one week to determine their daily caffeine consumption and will be asked to fill out the Caffeine Use Disorder Scale. Thus, they will be divided into low and high caffeine consumption groups and their speech understanding skills in noise will be compared.


Eligibility criteria: Inclusion Criteria:

* For both groups, it was planned to include individuals who had no hearing loss (SSO\<25 dB nHL), no history of neurological or psychological disorders, were non-smokers, and did not use ototoxic drugs.

Exclusion Criteria:

Primary outcomes:
measure: Turkish Matrix Test
timeFrame: Before and 30 minutes after drinking coffee
Secondary outcomes:
measure: Caffeine Use Disorder Scale
timeFrame: Before consuming caffeine.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Aydin University
Study officials:
References:
Clinical trial NCT04460417: Chicago Community Health Study
Official title: Health Behavior and Feedback Among Chicago Area Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study examined smokers from the initial COMPASS survey who live in one of three local Census tracks with large concentrations of minority populations and smoking rates, including Washington Park (98.8% African American, 60.5% smoker), Gage Park (76.7% Hispanic, 26.7% smoker), and Bridgeport (34.5% Asian, 27.0% Hispanic, 29.3% smoker), randomizing them to receipt of treatment as usual care advice (via a pamphlet form the National Cancer Institute) versus theoretically-driven and empirically-supported smoking cessation advice session delivered in-person at the UCM.


Eligibility criteria: Inclusion Criteria:

* Currently reside in either the Washington Park, Gage Park, or Bridgeport communities based on current physical address at the time of initial contact for study participation
* Identify as a current smoker (verified by self-report and exhaled carbon monoxide)
* Willing and able to sign an informed consent
* Stable residence and contact information throughout the follow-up period

Exclusion Criteria:

* Not a current smoker
* Does not live within the pre-determined neighborhood locations
* Unable to sign informed consent

Primary outcomes:
measure: Smoking reduction
timeFrame: Past-week CPD at 1- and 6-month follow-up
measure: Quit attempts
timeFrame: Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up
measure: Motivation to change smoking
timeFrame: Increases in stage of change at 1- and 6-month follow-ups
measure: Nicotine Replacement Therapy (NRT) use
timeFrame: Any reported NRT use since last session at 1- and 6- month follow-up
measure: Nicotine Replacement Therapy (NRT) knowledge
timeFrame: More accurate knowledge about NRT at 1- and 6-month follow-ups
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrea King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brett EI, Chavarria J, Liu M, Hedeker D, King AC. Effects of a brief motivational smoking intervention in non-treatment seeking disadvantaged Black smokers. J Consult Clin Psychol. 2021 Apr;89(4):241-250. doi: 10.1037/ccp0000629. Epub 2021 Mar 11.