louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06901856: Endoscopic Resection for Small Rectal Neuroendocrine Tumors
Official title: Modified Cap-assisted Endoscopic Mucosal Resection and Modified Endoscopic Mucosal Resection with a Ligation Device for Small Rectal Neuroendocrine Tumors Less Than 1 Cm: a Muticenter Randomized Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Neuroendocrine Tumor
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 120
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: TREATMENT

Brief summary: According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.

Detailed description: We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 80 years;
2. With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
3. With tumor size ≤10 mm assessed by colonoscopy;
4. Plan to receive mEMR-C or mEMR-L treatment and provide written informed consent;

Exclusion Criteria:

1. Unable to tolerate mEMR-L or mEMR-C as assessed by the research team of each center;
2. Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
3. Rectal NET with lymph node metastasis or distant metastasis;
4. Received resection of rectal neuroendocrine tumor by other surgical procedures;
5. Multiple rectal neuroendocrine tumors;
6. Vulnerable groups such as pregnant women or patients with mental disorders;
7. Poor compliance, unable to cooperate with treatment.

Primary outcomes:
measure: histological complete resection
timeFrame: within 14 days after procedure
Secondary outcomes:
measure: success rate of operation
timeFrame: intraoperative
measure: en bloc resection
timeFrame: intraoperative
measure: operation time
timeFrame: intraoperative
measure: complications
timeFrame: within 14 days after procedure
measure: length of stay
timeFrame: within 14 days after procedure
measure: hospitalization cost
timeFrame: within 14 days after procedure
measure: operation cost
timeFrame: within 14 days after procedure
measure: histopathologic grade
timeFrame: within 14 days after procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03846856: The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
Official title: The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with epithelium ovarian cancer who have undergone or who plan to undergo surgery

Brief summary: The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with epithelium ovarian cancer who have undergone surgery

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Involvement of IGF Axis in Ovarian Cancer
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ilan Bruchim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06275256: Outcomes of MIST for BPH: A Single-Institution Prospective Study
Official title: Outcomes of Minimally Invasive Surgical Treatments (MIST) for Benign Prostatic Hyperplasia (BPH): A Single-Institution Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile.

Detailed description: This prospective study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients who are to undergo Rezum or iTind procedure for BPH/LUTS between March 2024 and March 2025 are to be included in the study. Patient meeting inclusion criteria and exclusion criteria will be recruited to participate in this study.

Inclusion criteria: patients \> 18 years of age, undergoing Rezum or iTind treatment Exclusion criteria: ASA III or higher, active UTI within past week, age \< 18 years of age, no informed consent Follow-up/data measurements will occur pre-procedure, immediately post procedure, 1 week, 6 weeks, and 3 months following procedure. At time of consultation pre-procedure, baseline symptom scores, uroflow parameters will be obtained. VAS pain score is to be obtained during procedure, immediately post procedure, and at time of catheter or device removal 1 week post procedure. Uroflow parameters and symptoms scores will be again measured at 6 weeks and 3 months.

Eligibility criteria: Inclusion Criteria:

* patients \> 18 years of age undergoing Rezum or iTind treatment

Exclusion Criteria:

* ASA 3 or higher, active UTI within past week, age \< 18 years of age, no informed consent

Primary outcomes:
measure: Symptom Scores
timeFrame: 1, 3, 6 months post-procedure
measure: Uroflow
timeFrame: 1, 3, 6 months post-procedure
measure: Uroflow
timeFrame: 1, 3, 6 months post-procedure
measure: Symptom Scores
timeFrame: 1, 3, 6 months post-procedure
measure: Symptom Scores
timeFrame: 1, 3, 6 months post-procedure
measure: Symptom Scores
timeFrame: 1, 3, 6 months post-procedure
Secondary outcomes:
measure: Pain Scale
timeFrame: 1, 3, 6 months post-procedure
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Men's Health Clinic
state: Manitoba
Study officials:
References:
Clinical trial NCT05752656: Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
Official title: Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 100
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 affected by Parkinson's disease and candidates to intervention of deep brain stimulation.

Brief summary: The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.


Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
* patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson's disease" (CAPSIT-PD).

Exclusion Criteria:

- patients unable to give informed consent.

Primary outcomes:
measure: Improvement of quality of life
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Flavia Torlizzi
Study officials:
References:
Clinical trial NCT03576456: Sedative Premedication in Coronary Angiography
Official title: Sedative Premedication in Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Angiography
Sedative Premedication
Keywords: coronary angiography
premedication
pain
anxiety
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo controlled, double blind
Primary purpose: TREATMENT

Brief summary: Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.

Detailed description: Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.

Eligibility criteria: Inclusion Criteria:

* elective coronary angiography

Exclusion Criteria:

* planned PCI
* use of sedative medication at home
* use of alcohol

Primary outcomes:
measure: preprocedural anxiety: visual analogue scale
timeFrame: Assessed before the coronary angiography
measure: periprocedural pain: visual analogue scale
timeFrame: Assessed after the coronary angiography, within 4 hours.
Secondary outcomes:
measure: radial spasm
timeFrame: during procedure
measure: vascular site access complication
timeFrame: during procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Adriaan Wilgenhof
state: Jette
Study officials:
affiliation: Head of service
name: Danny Schoors, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01045356: Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass
Official title: Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 55
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with congenital heart defects having cardiac surgery requiring cardiopulmonary bypass

Brief summary: The purpose of this study is to measure blood levels of TXA in children having cardiac surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery. This study will help determine if the current dosing of TXA results in therapeutic blood levels.


Eligibility criteria: Inclusion Criteria:

* congenital heart disease requiring surgical repair with cardiopulmonary bypass

Exclusion Criteria:

* children weighing over 20 kg
* family does not want to participate in the study

Primary outcomes:
measure: Determine TXA blood levels in children having cardiac surgery with cardiopulmonary bypass. The current dosing recommendations will be utilized.
timeFrame: multiple times thoughout surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
citation: Dowd NP, Karski JM, Cheng DC, Carroll JA, Lin Y, James RL, Butterworth J. Pharmacokinetics of tranexamic acid during cardiopulmonary bypass. Anesthesiology. 2002 Aug;97(2):390-9. doi: 10.1097/00000542-200208000-00016.
Clinical trial NCT06163456: Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
Official title: Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Arterial Stiffness
Lead sponsor: Towson University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits. As only \~50% of cardiovascular (CV) events can be explained by traditional CV risk factors such as high blood pressure and high cholesterol, it is anticipated that this research will provide a more comprehensive look into novel risk factors that may better explain CV risk and that may be modifiable through regular physical activity.


Eligibility criteria: Inclusion Criteria:

* 18-29 years of age; healthy male and female; Physically inactive, defined as participation in less than 20 min of continuous endurance exercise on fewer than 2 days/week; Recreationally active, defined as participation in 30 min/day of moderate-intensity cardiovascular activity on greater than 4 days/week; Highly active- defined as performing 30-60 min of moderate- to vigorous-intensity endurance exercise greater than 5 days/week.

Exclusion Criteria:

* currently pregnant, previously diagnosed coronary heart disease or congenital heart disease, serum total cholesterol \>200 mg/dl, low-density lipoprotein cholesterol \>130 mg/dl, high-density lipoprotein cholesterol \< 35 mg/dl, fasting glucose \>100 mg/dl, systolic blood pressure \> 130 mmHg, diastolic blood pressure \>90 mmHg, and BMI \>30 kg/m2.

Primary outcomes:
measure: endothelial function
timeFrame: Baseline and 60 min post-exercise
measure: arterial stiffness
timeFrame: Baseline and 60 min post-exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Towson
country: United States
facility: Towson University
state: Maryland
Study officials:
affiliation: Towson University
name: Rian Q Landers-Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02385656: The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
Official title: The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fatigue
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

Detailed description: This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.

Eligibility criteria: Inclusion Criteria:

* solid cancer patient
* age of 20-65 years old
* subjects who scored =4 or \>4 on the Brief Fatigue Inventory
* subjects with informed consent

Exclusion Criteria:

* metastatic cancer(stage IV)
* with psychotic symptoms such as delusion and hallucination or with suicidal risk
* with delirium or dementia
* current medication of cognitive enhancer or psychostimulant uncontrolled medical illness
* current medications that are contraindicated or not recommended for co-administration with modafinil

Primary outcomes:
measure: severity of fatigue (Brief Fatigue Inventory)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Psychiatry, Seoul National University Bundang Hospital
name: Inyoung Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431856: CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
Official title: CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Traumatic Stress Disorder
Keywords: COVID-19
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.


Eligibility criteria: Inclusion Criteria:

* consent to participate via RedCap
* indicate a mild or greater elevation on screening measures of anxiety, depression and/or traumatic stress
* have a child between 6 and 13 years
* speak/read English or Spanish fluently

Exclusion Criteria:

* reported severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual disability, psychosis, alcohol use disorder, substance use disorder) or hospitalization for mental health concerns or suicide attempt.
* reported prior arrest for child endangerment, child abuse or child neglect, or prior investigation by the Florida Department of Children and Families (DCF)
* may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate

Primary outcomes:
measure: Measure of Anxiety as assessed by the OASIS
timeFrame: week 6 and week 12
measure: Measure of Depression as assessed by the ODSIS
timeFrame: week 6 and week 12
measure: Measure of PTSD as assessed by the PCL-5
timeFrame: week 6 and week 12
Secondary outcomes:
measure: Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU
timeFrame: week 6 and week 12
measure: Measure of Parenting Rejection as assessed by the S-EMBU
timeFrame: week 6 and week 12
measure: Measure of Parenting Emotional Warmth as assessed by the S-EMBU
timeFrame: week 6 and week 12
measure: Measure of Parent Accommodation for Child Anxiety as assessed by the FASA
timeFrame: week 6 and week 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02158156: Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
Official title: Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oculopharyngeal Muscular Dystrophy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.

Participants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.


Eligibility criteria: Inclusion Criteria:

* Danish patients with Oculopharyngeal muscular dystrophy

Exclusion Criteria:

* Patients who are too week to train on an cycle-ergometer for 10 weeks
* Patients with other health issues wich confound the interpretation of the efficacy.

Primary outcomes:
measure: Efficacy based on VO2max
timeFrame: 10 weeks
Secondary outcomes:
measure: SF-36 Questionaire
timeFrame: 10 weeks
measure: 6 minute walk test
timeFrame: 10 weeks
measure: Intensity in maximal load (Watt)
timeFrame: 10 weeks
measure: Level of plasma creatine kinase
timeFrame: 10 weeks
measure: Level of plasma myoglobin
timeFrame: 10 weeks
measure: 6 minute walk test
timeFrame: 10 weeks
measure: A five-time-repetition-sit-to-stand-test
timeFrame: 10 weeks
measure: A 14-step-stair-test
timeFrame: 10 weeks
measure: Dynamometry
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit
Study officials:
affiliation: Neuromuscular Research Unit, Rigshospitalet, Denmark
name: Karen BH Pedersen, Bsc.med.
role: PRINCIPAL_INVESTIGATOR
References: