louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01488032: Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma
Official title: Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma With Similar Structural Optic Nerve Damage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Tension Glaucoma
High Tension Glaucoma
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic University hospital of Dresden

Brief summary: The purpose of the study is to prove if there is any difference in the nerve fiber layer between patients with normal- and high-tension-glaucoma with similar structural optic nerve head parameters.

Detailed description: It is till now not definitely clear whether normal- and high-tension glaucoma are different forms of the same disease and whether they have similar pathogenetic mechanisms. Spectral domain optical coherence tomography (SD-OCT) is supposed to objectively evaluate retinal nerve fiber layer (RNFL) thickness. The investigators propose a study to compare the RNFL in patients with normal- and high-tension-glaucoma. In order to exclude other possible differences,which could influence the results, only patients with similar structural optic nerve head damage in both groups will be compared.

Eligibility criteria: Inclusion Criteria:

* persons over 18 years
* men or women
* with normal- and high-tension glaucoma

Exclusion Criteria:

* cataract
* cloudy cornea and other conditions with bad visualisation quality of optic nerve head
* optic nerve atrophy except glaucomatous

Primary outcomes:
measure: RNFL in different segments
timeFrame: up to 9 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06790732: Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
Official title: The Effect of Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative
Ultrasound-Guided
PeriCapsular Nerve Group Block
Postoperative Analgesia
Shoulder Arthroscopic Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the analgesic efficacy of preoperative ultrasound-guided peri-capsular nerve group block (PENG) on postoperative analgesia after shoulder arthroscopic surgery.

Detailed description: Postoperative pain control after shoulder surgery is challenging, and poor pain management is invariably reflected in poor outcomes, with longer hospitalization and recovery time. The difﬁculty in reducing pain due to the complexity of shoulder innervation leads to conducting studies to explore selective axillary nerve blocks with a posterior approach or from the axillae.

The peri-capsular nerve group (PENG) block is a regional anesthetic technique. It can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. It targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for better physical therapy, and earlier discharge.

Eligibility criteria: Inclusion Criteria:

* Age from 21 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-III.
* Scheduled for unilateral shoulder arthroscopic surgery.

Exclusion Criteria:

* Patient refusal.
* Known hypersensitivity to local anesthetics.
* Body mass index\> 35 kg /m2.
* Uncooperative or psychiatric patients.
* Infection at the injection site.
* Coagulation disorder.
* Major cardiac, renal, or hepatic diseases.

Primary outcomes:
measure: Time to the first request of rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06758232: Spine School for Parents With Disabled Children
Official title: Spine School for Parents With Disabled Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Deformity
Keywords: Disabled Children
Parents
Spine health
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our first aim in this study is to investigate the effects of neck exercise and information training given to parents of disabled children with non-specific neck pain on parameters such as pain, disability level, quality of life, posture, physical activity, and spinal curvature.


Eligibility criteria: Inclusion Criteria:

* Volunteer parents between the ages of 18-65, with spinal problems and chronic pain, pain lasting longer than 3 months, no inflammatory pain, no pain originating from abdominal-pelvic organs will be included in the study.

Exclusion Criteria:

* Individuals with acute fractures and malignancies, cervical disc herniation, those who have undergone surgical operations in the cervical region or spine, those with upper extremity pathologies, and those with rheumatological, neurological and psychological disorders will be excluded from the study.

Primary outcomes:
measure: Assessment of Neck Pain
timeFrame: 20 weeks
measure: Assessment of Neck Pain
timeFrame: 20 weeks
measure: Neck Disability Assessment
timeFrame: 20 weeks
measure: Evaluation of Neck Joint Range of Motion
timeFrame: 20 weeks
measure: Evaluation of Spinal Curvature
timeFrame: 20 weeks
measure: Posture Evaluation
timeFrame: 20 weeks
measure: Physical Activity Evaluation
timeFrame: 20 weeks
measure: Assessment of Quality of Life
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Atahan Turhan
state: Merkez
Study officials:
References:
Clinical trial NCT05887232: Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars
Official title: Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CO2 Laser in Scars
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.

Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.

Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is \<25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is \>75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value \<0.05 as significant, was used.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-50 years
* Fitzpatrick skin type III-V
* Presented with post-acne, post traumatic or post burn scars
* all those patients emotionally balanced with realistic expectations were included in the study.

Exclusion Criteria:

* scar that was less than 6 months old
* if they had an active infection or inflammatory skin condition
* having a history of malignancy
* a known connective tissue illness
* history of excessive bleeding or keloids
* unrealistic expectations
* pregnant or breastfeeding.

Primary outcomes:
measure: Quartile grading scale for assessment of scars
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Dr.Zahra Nigar
state: KPK
Study officials:
References:
Clinical trial NCT03921632: Impact of an Oral Health Intervention
Official title: Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Keywords: Anorexia nervosa
Bulimia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 46
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.


Eligibility criteria: Inclusion Criteria:

* Patient of the UNC Center for Excellence for Eating Disorders inpatient unit or outpatient clinic.
* Diagnosis of anorexia nervosa or bulimia nervosa
* Aged 13-50 years
* English-speaking

Exclusion Criteria:

* Decisionally impaired (i.e., Incapable of providing informed consent in the opinion of the primary care provider in UNC Center for Excellence for Eating Disorders)
* Involuntarily committed to the inpatient service of the UNC Department of Psychiatry

Primary outcomes:
measure: Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders
timeFrame: Baseline, Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center of Excellence for Eating Disorders Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Roberts, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silverstein LS, Haggerty C, Sams L, Phillips C, Roberts MW. Impact of an oral health education intervention among a group of patients with eating disorders (anorexia nervosa and bulimia nervosa). J Eat Disord. 2019 Sep 5;7:29. doi: 10.1186/s40337-019-0259-x. eCollection 2019.
Clinical trial NCT06490432: Pattern of Cardiac Arrhythmia in Patients With MASLD
Official title: Pattern of Cardiac Arrhythmia in Patients With Metabolic Dysfunction -Assocatied Steatotic Liver Disease in Sohag University Hospital.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrhythmia
Metabolic Dysfunction Associated Steatotic Liver Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study relationship between patients with metabolic dysfunction -assocatied steatotic liver disease and cardiac arrhythmia in those patients

Brief summary: Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients

Detailed description: Study the cardiac arrhythmia that could be occur in patients suffering form metabolic dysfunction -assocatied steatotic liver disease and risk factors of them

Eligibility criteria: Inclusion Criteria:

* patients aged 18years or older Patients with metabolic dysfunction -assocatied steatotic liver disease

Exclusion Criteria:

* RHD Structural heart diseases Liver diseases other than MASLD

Primary outcomes:
measure: Cardiac arrhythmia and MASLD patients
timeFrame: 1 year
measure: Cardiac arrhythmia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
state: So
Study officials:
affiliation: Sohag University
name: Mohamed Ahmed Mostafa, Lecturer
role: STUDY_DIRECTOR
References:
citation: Lee HH, Lee HA, Kim EJ, Kim HY, Kim HC, Ahn SH, Lee H, Kim SU. Metabolic dysfunction-associated steatotic liver disease and risk of cardiovascular disease. Gut. 2024 Feb 23;73(3):533-540. doi: 10.1136/gutjnl-2023-331003.
Clinical trial NCT04289532: Integrin α6-targeted SPECT Imaging of Breast Cancer
Official title: First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Breast cancer
integrin α6
SPECT
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: China-Japan Union Hospital, Jilin University
name: Sun Yat-sen University
First posted: 2020-02-28
Enrollment: 9
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.

Detailed description: Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.

Eligibility criteria: Inclusion criteria:

* Healthy volunteers.
* Body mass index (BMI) at 19 to 25 \[Body mass index = body weight (kg)/ height squared (m2)\];
* Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance;
* Informed written consents were obtained from all 9 subjects before the procedure.
* Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information.

Exclution Criteria:

• The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.

Primary outcomes:
measure: Blood Clearance
timeFrame: 1,3,5,10,15,30,60,120 minutes post-injection
measure: Excretion
timeFrame: 0-24 hours post-injection
measure: Biodistribution
timeFrame: 0.5,1,2,4,24 hours post-injection
measure: SPECT/CT imaging
timeFrame: post-injection
measure: Distributed in organs
timeFrame: 0.5,1,2,4,24 hours post-injection
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1 week post-injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Health Science Center
state: Beijing
Study officials:
References:
Clinical trial NCT04722432: Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study
Official title: Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed. Using this novel system, the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe.

Detailed description: Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs. Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach, potentially improving safety and reducing related morbidity. Application and deployment of this system allows the operator to have constant control of the airway, preventing life-threatening hemoptysis and other complications. We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future.

Eligibility criteria: Inclusion Criteria:

* Patients who follow surgery for the removal of diseased lungs before being submitted to a bilateral lung transplant.

Exclusion Criteria:

* None

Primary outcomes:
measure: accuracy of the deployment method
timeFrame: Time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
References:
Clinical trial NCT06006832: A Prospective Cohort Study of Myasthenia Gravis in China
Official title: Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.

Brief summary: The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:

1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.
2. To identify potential biomarkers that can predict disease progression and prognosis.

This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.


Eligibility criteria: Inclusion Criteria:

* 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.
* 2: Diagnosed as myasthenia gravis.
* 3: Follow-up time at PUMCH\>6 months.
* 4: The patient understood and signed the informed consent form.

Exclusion Criteria:

* 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess
* 2: Records related to comorbidities and medications were not available at baseline and during follow-up.

Primary outcomes:
measure: Relapse of myasthenia gravis
timeFrame: Within two years after recruitment
Secondary outcomes:
measure: Time of relapse
timeFrame: Within two years after recruitment
measure: Change of MG assessment scales at relapse
timeFrame: Within two years after recruitment
measure: Adverse events of steroids
timeFrame: Within two years after recruitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuzhou Guan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380132: Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Official title: Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Treatment
Surgery
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2011-06-27
Enrollment: 35
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Detailed description: Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

Eligibility criteria: Inclusion Criteria:

* Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
* Age 18-80
* Available for follow-up for the duration of the study
* Written informed consent.

Exclusion Criteria:

* Sphincter defect visible on anal ultrasound.
* Pregnancy.
* Rectal prolapse or inflammatory bowel disease.
* Recent (within 6 months) anal surgery except for haemorrhoids.
* Anorectal sepsis.
* Anticoagulant medication or bleeding diathesis.

Primary outcomes:
measure: Treatment response as measured by a 50% reduction in no of incontinence episodes.
timeFrame: One year posttreatment
Secondary outcomes:
measure: Adverse events
timeFrame: One year posttreatment
measure: Global assessment
timeFrame: One year posttreatment
measure: Change in incontinence episodes
timeFrame: One year posttreatment
measure: Quality of life
timeFrame: One year posttreatment
measure: Adverse events
timeFrame: Two years posttreatment
measure: Global assessment
timeFrame: Two years posttreatment
measure: Change in incontinence episodes
timeFrame: Two years posttreatment
measure: Quality of life
timeFrame: Two years posttreatment
measure: Treatment response as measured by a 50% reduction in no of incontinence episodes.
timeFrame: Two years posttreatment
Other outcomes:
Locations:
city: 751 82 Uppsala
country: Sweden
facility: Department of Surgery, University Hospital
Study officials:
affiliation: Inst of Surgical Sciences, Uppsala university
name: Wilhelm JR Graf, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.