louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05143775: Strategic Intervention on Preserving Language Function During Awake Craniotomy
Official title: Strategic Intervention on Preserving Language Function During Awake Craniotomy for Glioma Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: functional preservation
awake craniotomy
language impairment
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to compare the language function after traditional or a new surgical plan during awake craniotomy for glioma resection.

Detailed description: This study concentrates on patient who has type II language area glioma occupation. The investigators designed new surgical plan which is using monopolar stimulator to determine and retain the tumor margin within 5 mm from the posterior superior longitudinal fasciculus or posterior arcuate fasciculus. For the tradiitional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After they positive points are identified by stimulator, the positive points are retained to preserve the motor function while all the negative points of the tumor are resected. This study is to determine whether the new surgical plan is more suitable for type II language area glioma occupation.

Eligibility criteria: Inclusion Criteria:

1, patients with glioma near or on the language function area that have the necessity to undergo awake craniotomy and language function identification during tumor resection

Exclusion Criteria:

1. patients with incompleted monitoring procedures;
2. paitents without data of the pre-and postoperative resting state MRI, diffuison tensor image and functional MRI.

Primary outcomes:
measure: Change of the language impairment rate
timeFrame: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
measure: Change of the survival rate
timeFrame: From date of the first tumor resection until the date of death from any cause, assessed up to 500 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Neurosurgical Institute
name: Jiang Tao
role: STUDY_CHAIR
References:
citation: Fang S, Liang Y, Li L, Wang L, Fan X, Wang Y, Jiang T. Tumor location-based classification of surgery-related language impairments in patients with glioma. J Neurooncol. 2021 Nov;155(2):143-152. doi: 10.1007/s11060-021-03858-9. Epub 2021 Oct 1.
Clinical trial NCT06265675: Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve
Official title: Comparison of the Efficacy of Ultrasound-Guided Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Genicular nerve
Phenol
Knee Osteoarthritis
Neurolysis
Nerve Blockage
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block.

Detailed description: Knee osteoarthritis is one of most frequent reason of knee pain. There are different treatment methods such as analgesic drug treatment, physical therapy techniques, intraarticular injections and neurolysis techniques. In this study, we will compare neurolysis techniques these are phenol block and corticosteroid local anesthetic block.

Eligibility criteria: Inclusion Criteria:

* Patients with knee osteoarthritis must have pain at least 6 months
* NRS score of knee pain equal or more than 5
* At least grade 3 in Kellgren-Lawrence grading scale
* Non responsive to life style change, weight control, exercises program, medical treatment and the other conservative treatments (physical therapy, intraarticular injections)
* Decreasing at NRS score more than %50 after diagnostic block
* Those who accept the consent form

Exclusion Criteria:

* Patients who have acute knee injury
* Surgery history in knee
* Connective tissue disease that affect knee
* Sciatica
* Injection story in last 3 months
* Psychiatric or neurologic diseases that affect study
* Septic arthritis, active local or systemic infection
* Coagulopathy
* Pregnancy
* Allergic reaction

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Before the intervention, 4 weeks after the intervention and 3 months later
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Before the intervention, 4 weeks after the intervention and 3 months later
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4 weeks after the intervention and 3 months later
measure: Sixt Minute Walk Test (6MWT)
timeFrame: Before the intervention, 4 weeks after the intervention and 3 months later
measure: The Timed-Up and Go test
timeFrame: Before the intervention, 4 weeks after the intervention and 3 months later
measure: Frequency of analgesic usage
timeFrame: Before the intervention, 4 weeks after the intervention and 3 months later
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler
state: Çankaya
Study officials:
References:
Clinical trial NCT02890875: Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
Official title: Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheter-Related Infections
Keywords: ethanol lock
parenteral nutrition
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 3
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: PREVENTION

Brief summary: Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.


Eligibility criteria: Inclusion Criteria:

* Adult patients (ages 18-80) on PN with silicone-based central venous catheters

Exclusion Criteria:

* Weight ≤ 50 kg
* Allergy/hypersensitivity/intolerance to ethanol or heparin
* Pregnancy or breastfeeding
* Patient taking metronidazole, disulfiram, or isoniazid
* History of alcohol abuse
* History of heparin-induced thrombocytopenia (HIT) or have an active hypocoagulable state

Primary outcomes:
measure: Central line-associated bloodstream infection
timeFrame: 12 months
Secondary outcomes:
measure: Hospitalization
timeFrame: 12 months
measure: SIRS/sepsis
timeFrame: 12 months
measure: Catheter-related complication
timeFrame: 12 months
measure: New self-reported symptoms
timeFrame: 12 months
Other outcomes:
measure: Microorganism (blood culture, if obtained for clinical reasons)
timeFrame: 12 months
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Berkeley Limketkai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566575: Isthmocele - Prediction, Prevention, Diagnosis, and Management
Official title: Isthmocele - Prediction, Prevention, Diagnosis, and Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isthmocele
Keywords: Caesarean section
Myometrium
Hydrometra
transvaginal ultrasound
Isthmocele correction
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgery for isthmocele at the University Hospital Basel between 01.01.2017 and 31.12.2020. Time interval from the operation performed to the study-specific consultation has a maximum of 4 years.

Brief summary: An Isthmocele is a scar defect or uterine niche that develops in the myometrium due to an inadequate healing process at the site of the caesarean section incision. The management of isthmocele is not standardized and a correction typically involves invasive procedures (hysteroscopy/resectoscopy, laparoscopy, vaginal surgery). This study is to investigate the effectiveness of the procedures used to treat isthmocele.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing isthmocele correction surgery within the period from 01.01.2017 to 31.12.2020 at the University Hospital Basel, Women's Hospital

Exclusion Criteria:

* Missing information on the preoperative initial situation (preoperative myometrium thickness, lack of imaging via TVUS)
* Missing information on key characteristics that are important in the collection of retrospective data analysis (e.g. data on the previous caesarean section)
* Inability to give an informed consent
* Lack of German language skills

Primary outcomes:
measure: Myometrium thickness after isthmocele correction procedure (mm)
timeFrame: single time-point at baseline (approx. 10 minutes)
measure: Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure
timeFrame: single time-point at baseline (approx. 10 minutes)
measure: Patient satisfaction after isthmocele correction procedure
timeFrame: single time-point at baseline (approx. 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Women's Hospital
Study officials:
affiliation: University Hospital Basel, Women's Hospital
name: Viola Heinzelmann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01237275: Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients
Official title: Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Continuous Antidepressant Abuse
Adverse Reaction to Drug
Keywords: Pharmacogenomics
Prediction of Antidepressant Response
Depressed Patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First, the investigators examined the functional relevance of serotonin transporter polymorphisms by quantifying the activity of serotonin transporter in blood platelets of genotyped healthy volunteers and patients with major depression.

Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also to the functional expression of 5-HTT in platelets.

Detailed description: The purpose of this study is

1. to determine whether serotonin transporter genotypic or functional differences between depressive patients and normal controls were existed.
2. to determine the relationship between serotonin transporter polymorphisms and serotonin transporter functional expression.
3. to determine whether genomic or functional differences between drug responders and nonresponders predict the response of antidepressant

Eligibility criteria: Inclusion Criteria:

* Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
* interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

* received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
* potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: Antidepressant Response at 2,4,6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Biological value at 0 and 6 weeks
timeFrame: 6weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232475: Effect of Stair Climbing and Descending on Postprandial Blood Glucose
Official title: Effect of Stair Climbing and Descending on Postprandial Blood Glucose Following Mixed Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Blood Glucose
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Determine effect of stair climbing and descending on postprandial blood glucose

Detailed description: Determine effect of 1, 3, and 10 minutes of stair climbing and descending on postprandial blood glucose compared to seated control following consumption of mixed meal

Eligibility criteria: Inclusion Criteria:

* within specified age limit, ability to climb and descend stairs determined by ACSM's PAR-Q

Exclusion Criteria:

* diagnosis of diabetes or use of diabetic medications

Primary outcomes:
measure: Postprandial blood glucose
timeFrame: 15 minutes
measure: Postprandial blood glucose
timeFrame: 30 minutes
measure: Postprandial blood glucose
timeFrame: 45 minutes
measure: Postprandial blood glucose
timeFrame: 60 minutes
measure: Postprandial Insulin
timeFrame: 15 minutes
measure: Postprandial Insulin
timeFrame: 30 minutes
measure: Postprandial Insulin
timeFrame: 45 minutes
measure: Postprandial Insulin
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT02015975: Clinical Outcome After Treatment of Patellar Fractures With Locking Plates
Official title: Clinical Outcome After Treatment of Patellar Fractures With Locking Plates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of Patella
Keywords: patellar fracture
fracture of patella
patella
locking plate osteosynthesis
osteosynthesis
star-plate
arrow-plate
Lead sponsor: Diakoniekrankenhaus Friederikenstift
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a fracture of the patellar, which were operated with a locking plate osteosynthesis in the Friederikenstift Hannover since May 2013.

Brief summary: Depending on the fracture pattern of patellar fractures tension band wiring, interfragmentary screw fixation or combinations are common treatments. But there are several problems associated with these techniques as fracture dislocation or loosening and perforation of the wire. Furthermore an anatomic reduction with stable fixation in comminuted fractures is almost impossible to achieve.

A new option in the treatment of patellar fractures is the locking plate osteosynthesis, which provides a more stable fixation and higher mechanical strength in biomechanical tests compared to classic tension band wiring. Due to various screw positioning a stable fixation in comminuted fractures can be achieved and an early functional treatment with full weight bearing reduces the loss of knee-motion. Furthermore a removal of the osteosynthesis seems not to be essential anymore and the blood supply is not to be compromised.

Because of the absent of clinical evidence investigators want to evaluate the clinical outcome after locking plate osteosyntheses in patellar fractures and compare patient satisfaction, functional motion, complications and number of revisions with common treatments.


Eligibility criteria: Inclusion Criteria:

* patients with indication for operative treatment of a patellar fracture
* sufficient compliance
* signed patient information

Exclusion Criteria:

* preoperative disease or trauma of the patellar
* preoperative loss of motion of the knee
* former operations of the patellar
* alcohol or drug consumption

Primary outcomes:
measure: Clinical short-term results
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical long-term results
timeFrame: 24 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Diakoniekrankenhaus Friederikenstift Hannover
state: Niedersachsen
Study officials:
affiliation: Friederikenstift Hannover
name: Alexander Ellwein, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellwein A, Lill H, DeyHazra RO, Smith T, Katthagen JC. Outcomes after locked plating of displaced patella fractures: a prospective case series. Int Orthop. 2019 Dec;43(12):2807-2815. doi: 10.1007/s00264-019-04337-7. Epub 2019 Apr 30.
Clinical trial NCT05736575: Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients
Official title: Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: BDNF
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2023-02-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects will be selected if they have been suffering from musculoskeletal pain (not oncological) for at least 3 months.

Brief summary: A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people.

Detailed description: Brain-derived neurotrophic factor (BDNF) is considered a biomarker of brain plasticity. Since different alterations in brain plasticity have been found in chronic pain patients, the investigators want to study whether there are differences at the molecular level in this population compared to an asymptomatic population in order to be able to accurately measure the impact of different physiotherapy interventions in an objective way.

Eligibility criteria: Inclusion Criteria:

* males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
* patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
* not having received physiotherapy treatment for this same process in the last 3 months.
* ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.

Exclusion Criteria:

* Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.

Primary outcomes:
measure: BDNF Levels
timeFrame: 3 hours
measure: Pain Intensity
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Irf Cseuls
Study officials:
References:
Clinical trial NCT03659175: Characteristic of Intestinal Flora in Male Elderly With Small Intestinal Bacterial Overgrowth
Official title: Study on Clinical Features, Intestinal Flora and Standardized Treatment in Male Elderly With Small Intestinal Bacterial Overgrowth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Intestinal Bacterial Overgrowth
Elderly
Male
16s rRNA
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 40
Sex: MALE
Minimum age (years): 65
Maximum age (years): 98
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male elderly outpatients at Department of Gastroenterology, Nanlou Division, Chinese PLA General Hospita, Beijing, China

Brief summary: We will focus on the intestinal flora structure, risk factors and clinical features of male elderly with SIBO in our study.

Detailed description: Our previous study had found that the prevalence rate of small intestinal bacterial overgrowth(SIBO) in male elderly was high up to 63.1%. In the recent years, SIBO has been found be associated not only with abdominal symptoms such as abdominal distention, pain and so on, but also with various diseases such as diabetes, Alzheimer's disease, joint pain, chronic prostatitis, fatty liver, liver cirrhosis etc. SIBO has significant impact on the health of elderly. Methane and hydrogen lactulose breath test(LBT) is effective and noninvasive for the diagnosis of SIBO. High throughput sequencing is a leading technique for the study of intestinal microflora.

Although more and more studies have focused their concern on the intestinal flora now, few SIBO-related studies are available in elderly patients. But we have found SIBO was very popular in the elderly. The conflict between high prevalence rate of SIBO in elderly and very few relevant studies is barrier to study of pathophysiology, early diagnosis and treatment of SIBO in elderly adults.

So in our study, we will apply LBT and high throughput sequencing technique to study the intestinal flora structure, risk factors and clinical features of male elderly patients with SIBO. And further, we will try to develop standard treatment for elderly patients with SIBO.

Eligibility criteria: Inclusion Criteria:

* no use of antibiotics in the past 1 month, no use of prokinetic drugs and probiotics in the past 1 week

Exclusion Criteria:

* active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease

Primary outcomes:
measure: amplicon sequencing of intestinal microflora
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
Study officials:
affiliation: Director
name: Jun Wan
role: STUDY_DIRECTOR
References: