louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00546949: Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop
Official title: Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Radiculopathy
Keywords: Decompression, Surgical
x-stop
lumbar decompression
spinal stenosis
radiculopathy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)


Eligibility criteria: Inclusion Criteria:

* neurogenic intermittent claudication due to lumbar spinal stenosis
* diagnosed on MRI in maximum two levels
* walking distance on 250 metres
* symptom relief on flexion of the lumbar spine
* duration of the symptoms more than 6 months
* non-operative treatment is tried or considered as not indicated

Exclusion Criteria:

* vascular claudicatio intermittens
* spinal stenosis on more than 2 levels
* cauda equina syndrome
* severe paresis
* clinical monoradiculopathy
* grave scoliosis
* previous lumbar surgery
* degenerative spondylolisthesis more than 25%
* spondylolysis with listhesis
* osteoporotic fracture in lumbal column
* clinical and radiological (both) arthritis in the hip joint
* ASA \>3
* verified polyneuropathy on neurophysiological test

Primary outcomes:
measure: Claudication
timeFrame: 2 years
Secondary outcomes:
measure: self-evaluated health condition
timeFrame: 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Nastional Senter for Spinal Disorders
Study officials:
affiliation: Norwegian University of Sciense and Technology
name: Greger Lønne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard OP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.1097/BRS.0000000000000691.
citation: Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, Nygaard OP. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-20. doi: 10.1097/BRS.0000000000000798.
Clinical trial NCT04996849: Contemporary Characteristics of Penile Cancer
Official title: Contemporary Characteristics of Penile Carcinoma: at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, the Woodlands and Bay Area Regional Care Centers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Penile Carcinoma
Squamous Cell Carcinoma of the Penis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-09
Enrollment: 1000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a primary penile malignancy

Brief summary: This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.

Detailed description: PRIMARY OBJECTIVE:

I. To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers.

OUTLINE:

Patients undergo data collection every 6 months for up to 15 years.

Eligibility criteria: Inclusion Criteria:

* All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma

Exclusion Criteria:

* No patient meeting the above criteria will be excluded

Primary outcomes:
measure: Prospectively collect data on the presenting features, management and outcome of penile carcinoma
timeFrame: Up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Curtis A Pettaway
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002806: Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
Official title: A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Biliary Tract Cancer
Keywords: Pancreatic cancer
Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.

Detailed description: Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.

Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.

Eligibility criteria: Inclusion Criteria:

This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.

* Physiologic suitability for major abdominal surgery
* Aged 18 years and older
* Written informed consent
* Ability to understand and comply with study guidelines.

Exclusion Criteria:

* Pregnancy
* Previous, preoperative celiac nerve block
* Neoadjuvant chemotherapy or radiation therapy
* Incomplete tumor resection (R2 resection, grossly positive resection margin)
* Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
* Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings
* Known metastatic disease

Primary outcomes:
measure: Pain Control
timeFrame: 12 Months
Secondary outcomes:
measure: Disease-specific, recurrence-free survival
timeFrame: 2 Years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University, Department of Surgery
name: Michael G House, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934206: Predictors of Individual Training Effectiveness in Preventive Exercise
Official title: Pilot Study to Find Predictors of Individual Training Effectiveness in Preventive Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Keywords: Exercise
healthy subjects
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Yet, the extent of individual benefit differs considerably even within homogenous groups and the prediction of individual training effectiveness is not yet possible. This study aims to find predictors of individual training effectiveness.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* age 35-60

Exclusion Criteria:

* Any medical condition requiring medication (except thyroid hormones)
* Other complaints that might interfere with exercise

Primary outcomes:
measure: correlation of possible predictors with training effects on cardiovascular risk factors
timeFrame: within study periode
Secondary outcomes:
measure: Correlation of possible predictors with improvements in physical performance
timeFrame: within study period
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Institute of Sports- and Preventive Medicine, Saarland University
state: Saarland
Study officials:
affiliation: Institute of Sports- and Preventive Medicine, Saarland University
name: Anne Krieg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hecksteden A, Grutters T, Meyer T. Associations between acute and chronic effects of exercise on indicators of metabolic health: a pilot training trial. PLoS One. 2013 Nov 21;8(11):e81181. doi: 10.1371/journal.pone.0081181. eCollection 2013.
Clinical trial NCT03874806: Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block
Official title: Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Pain, Chest
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goals of this study are as follows:

1. to confirm the safe dosing of ropivacaine for the erector spinae plane block
2. develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block
3. assess numbness created by the erector spinae block when routine doses are administered


Eligibility criteria: Inclusion Criteria:

1. Participant's age is greater than 18 years
2. Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision
3. Participant's surgery is being performed by Dr. Vig Kasirajan

Exclusion Criteria:

1. Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis
2. Abnormal liver function tests demonstrated by lab results
3. Allergy to lidocaine, ropivacaine, or midazolam
4. Morbid obesity, defined as body mass index greater than 40
5. Existing skin neuropathy on the chest or back
6. Body weight less than 50 kg
7. Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation
8. Participant remains intubated on post-operative day 1
9. Pregnant women

Primary outcomes:
measure: Cmax
timeFrame: 28 hours
measure: Tmax
timeFrame: 28 hours
measure: Area of analgesia
timeFrame: 4 hours
measure: Duration of analgesia
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Bryant Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936906: Mohs Surgery: Patient Satisfaction & Quality of Life (QOL)
Official title: Patient Satisfaction Improvement and Quality of Life Measurement in Mohs Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine whether there is significant difference between two groups: extra care (EC) and usual care (UC) in improvement of patients' quality-of-life (QoL) scores between the baseline and 90-day post-surgery in patients undergoing Mohs micrographic surgery (MMS).


Eligibility criteria: Inclusion Criteria:

1. Female and/or male subjects undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) and/or Squamous Cell Carcinoma (SCC).
2. Subjects must be at least 18 years of age.

Exclusion Criteria:

1. Subjects who are not able to complete the surveys (pre-surgery, 1 week post-surgery, and 3 months post- surgery)
2. Subjects under the age 18
3. Subjects unable to consent
4. Subjects who are not undergoing Mohs micrographic surgery for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC).

Primary outcomes:
measure: Change in PSQ Scores
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430806: Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
Official title: Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ICD
ICD SHOCKS
DRONEDARONE
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion channel properties similar to amiodarone.

Several case reports have shown promising results with Dronedarone for this patient population.


Eligibility criteria: Inclusion Criteria:

* Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:

* CHF NYHA IV OR DECMPENSATED III
* PERMANENT AF
* LIVER DYSFUNCION
* CR CLEARANCE \<30

Primary outcomes:
measure: Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06418906: The Relationships Between Equanimity, Mindfulness, and Self-Compassion, and Mental Health Outcomes
Official title: The Relationships Between Equanimity, Mindfulness, and Self-Compassion, and Mental Health Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mindfulness
Mental Health Outcomes
Self-Compassion
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community participants aged 18 or above

Brief summary: This is an academic research study aiming to explore the relationships between equanimity, mindfulness, self-compassion, and mental health outcomes, and to examine the reliability and validity of the new measures in Hong Kong.

Detailed description: The current research aims to validate two new measures, the Equanimity Scale (ES-16) and the Sussex-Oxford Compassion for the Self Scale (SOCS-S) in Hong Kong. Standard procedures of forward-backward translation of the ES-16 and SOCS-S were employed. Adults aged 18 or above will be recruited in the community to fill out a set of questionnaires two times on equanimity, mindfulness, self-compassion, and mental health outcomes (i.e., depression, anxiety, stress, wellbeing). Relationships between these variables will be explored. To assess test-retest reliability, participants will be invited to fill out the same set of questionnaires on a total of two time points: baseline and two-week post-baseline.

Eligibility criteria: Inclusion Criteria:

* aged 18 or above
* can read and type Chinese
* have means to access online surveys

No Exclusion Criteria

Primary outcomes:
measure: Mindfulness (Five Facet Mindfulness Questionnaire - 20)
timeFrame: 2-week
measure: Equanimity (Equanimity Scale)
timeFrame: 2-week
measure: Self-compassion (Sussex-Oxford Compassion for the Self Scale)
timeFrame: 2-week
measure: Depression (Patient Health Questionnaire - 9)
timeFrame: 2-week
measure: Anxiety (Generalized Anxiety Disorder - 7)
timeFrame: 2-week
measure: Stress (Perceived Stress Scale - 10)
timeFrame: 2-week
measure: Wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale)
timeFrame: 2-week
measure: Equanimity (Two-Factor Equanimity Scale)
timeFrame: 2-week
measure: Self-compassion (Self-Compassion Scale - Short Form)
timeFrame: 2-week
Secondary outcomes:
measure: single-item measures on equanimity, mindfulness, self-compassion, depression, anxiety, stress (i.e., six items in total)
timeFrame: 2-week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Hoi Chun Lok, MSocSc(CP)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06860906: V-Y Flap for Anal Stenosis
Official title: Outcome of V-Y Anoplasty Techniques in Management of Anal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Stenosis
Keywords: anal stenosis, anoplasty, V-Y advancement flap
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-03-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: anal stenosis is a common complication after massive open hemorrhoidectomy. it interferes with the patient daily activities. Many interventions were described, but there is no standard treatment. Data were always lost about the best intervention. In this study we try to discover if V-Y advancement flap can effectively treat anal stenosis or not.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes aged ≥ 18years old with moderate to severe post- hemorrhoidectomy anal stenosis

Exclusion Criteria:

* pregant females
* patient with prior irridiation
* patient with T.B
* Patient with Crohn's disease

Primary outcomes:
measure: operative time
timeFrame: Intraoperative (operative time is measured in minutes from incision to wound dressing)
measure: pain score
timeFrame: from one day to 6 months postoperative
measure: bleeding amount
timeFrame: from incision to 2 weeks after surgery
measure: post-operative analgesia
timeFrame: from one day to 2 weeks post operative
measure: hospital stay
timeFrame: for 1 to 2 days after surgery
measure: healing time
timeFrame: healing duration in days calculated from the first day post operative to 3 months
Secondary outcomes:
measure: age
timeFrame: for 2 days before surgery
measure: sex
timeFrame: 2 days pre-operative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharqia
Study officials:
References:
Clinical trial NCT00247806: Prevalence of Lactose Intolerance Following Stem Cell Transplantation
Official title: Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lactose Intolerance
Keywords: Pilot, pediatric, stem cell transplant, lactose intolerance
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: It is currently assumed that all patients are lactose intolerant post bone marrow transplantation. This pilot study is to assess what the incidence of lactose intolerance is after bone marrow transplantation in children. This will be done using a lactose breath test.

Detailed description: All pediatric patients over the age of 4 years who are scheduled for a stem cell transplant will be approached to assess whether what the incidence of lactose intolerance is in the post transplant period and how quickly recovery occurs. A baseline lactose and lactulose breath test will be performed followed by repeat lactose breath tests starting 2 weeks after day 0 and repeated every fortnight for 10 weeks. Stool pH and reducing substances will be checked at the time of the breath tests to see if there is any correlation.

Eligibility criteria: Inclusion Criteria:

* All patients planned to undergo a stem cell transplant.

Exclusion Criteria:

* Refusal to participate
* Unable to perform breath tests on request (generally under the age of 4 years.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Colin Barker, PhD
role: PRINCIPAL_INVESTIGATOR
References: