louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06793722: Technological Devices in Circumcision
Official title: The Effect of Technological Devices on the Child's Pain and Anxiety Level in Circumcision Performed With Local Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circumcision Adult
Circumcision, Male
Circumcision
Keywords: circumcision
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 50
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. Previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain levels have been detected. The research will start with hospitalization and end with a check-up after discharge.


Eligibility criteria: Inclusion Criteria:

* Circumcision for medical or religious reasons.

Exclusion Criteria:

* Children with chronic diseases.
* Children with genital medical problems.
* Children with mental and communication disabilities and their parents.

Primary outcomes:
measure: change of child anxiety and worry
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Changes in anxiety and worry among parents.
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman University
Study officials:
References:
Clinical trial NCT04066322: Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment
Official title: Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Tumors
Metastases
Surgery
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center

Brief summary: This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.

Detailed description: system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.

Eligibility criteria: Inclusion Criteria:

1. Biopsy-proven neuroendocrine tumor
2. primary site in pancreas
3. Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis
4. curative intent of all therapies possible
5. ECOG 0-2

Exclusion Criteria:

1. Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor
2. functioning NET or advanced carcinoid heart disease
3. part of hereditary syndrome, such as MEN1, VHL
4. do not willing to receive systemic treatment
5. diagnosed with other cancer within 5 years

Primary outcomes:
measure: progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: Number of Postoperative morbidity
timeFrame: Up to 90 days after operation
measure: number of Postoperative mortality
timeFrame: Up to 90 days after operation
Other outcomes:
measure: number of Patients die from any cause during 90 days after operation
timeFrame: 5 years
measure: progression-free survival in subgroup analysis
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT01852422: Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Pop Medical Solutions
Sponsor class: INDUSTRY
First posted: 2013-05-13
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pelvic organ prolapse 21-80 years old

Brief summary: Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse surgery, there is a paucity of information regarding the identification of these structures outside of surgical dissection. Furthermore, there is no published data describing the relative distances between the apex of the vagina and these ligaments in women with prolapse. Recent developments in imaging have enabled the identification of the distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the subdivisions of the pubovisceralis. The visualization of these structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and in live humans, with excellent interrater reliability. The investigators propose to use this technology to explore the anatomy of the sacrospinous ligaments.


Eligibility criteria: Inclusion Criteria:

* age 21-80 years old
* Stage III or higher pelvic prolapse

Exclusion Criteria:

-Prior pelvic surgery

Primary outcomes:
measure: Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging
timeFrame: Real time during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee MC
Study officials:
References:
Clinical trial NCT06146322: Barley Beta-glucan, Glycemic Control, and Appetite
Official title: Barley Beta-glucan, Glycemic Control, and Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Blood Sugar; High
Diabetes
Appetite and General Nutritional Disorders
Appetitive Behavior
Keywords: Beta-glucan
Fiber
Glycemic Control
Appetite
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Body Mass Index (BMI) values of 18.5-40.0 kg/m2
* Normal fasting blood glucose (\<100 mg/dL)

Exclusion Criteria:

* Use of medications known to be associated with weight change (e.g., beta-blockers)
* Use of steroid pills or shots such as prednisone or cortisone
* Use of nicotine
* Weight change of ten or more pounds in the last three months
* Major daily variation in physical activity (e.g., athletes in training)
* History of extensive small bowel surgery or surgery to treat obesity
* History of heart attack, stroke, or bypass
* History of cancer within the last five years (exception: non-melanoma skin cancer)
* Recent or current medical diagnosis or medical treatment that would alter appetite, energy needs, satiety, and/or could impact the results of the trial
* Medical diagnoses of diabetes, cardiovascular disease, high levels of blood lipids, asthma, cold, and flu (exception: hypertension, if treated with medication prescribed more than three months prior to the screening activity)
* Fear of blood or needles
* Dietary restrictions that would interfere with consuming test foods (e.g., gluten intolerance, vegan, corn syrup allergy)
* Following a weight modification diet
* Sensitive to food textures present in the test foods
* Following personal schedules that would not permit attendance at all scheduled testing sessions
* Unable to comprehend the nature of the trial or instructions
* Unable to understand English sufficiently to complete the trial

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: 4 hours
measure: Subjective appetite
timeFrame: 4 hours
measure: Food intake
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Martine Perrigue, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06481722: Knee Joint Angle Affect Muscle Architecture in Children With Cerebral Palsy
Official title: Does Knee Joint Angle Affect Muscle Architecture in Children With Spastic Cerebral Palsy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spastic Cerebral Palsy
Keywords: muscle architecture
knee joint angle
cerebral palsy
spasticity
children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy, 40 diplegic cerebral palsy children of both sexes will participate in this study.

Brief summary: To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy

Detailed description: To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy

Eligibility criteria: Inclusion Criteria:

* A diagnosis of spastic diplegia CP.
* Age from 3 to 6 years.
* Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
* Level III motor function according to the Growth Motor Function Classification System.
* Hamstring muscle tightness.
* Able to understand and follow instructions.

Exclusion Criteria:

* Epilepsy.
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
* Structural or fixed soft tissue deformities of the lower extremities.
* Neurological or orthopedic surgery in the past 12 months.
* Botox injection in the lower extremities in the past 6 months.

Primary outcomes:
measure: Fascicle length
timeFrame: 3 months
measure: knee joint angle will be measured by digital Goniometer
timeFrame: 3 months
measure: pennation angle
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Mostafa S Ali
state: Married
Study officials:
References:
Clinical trial NCT05547022: Endovascular Limb Salvage in Trinidad and Tobago
Official title: Critical Limb Ischemia in Trinidad and Tobago- A Series of 157 Endovascular Limb Salvage Attempts in Patients With CLTI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb Salvage Rates With Endovascular Therapy
Keywords: Critical limb-threatening ischemia (CLTI); Endovascular revascularization (EVR); Peripheral arterial disease (PAD); Peripheral vascular disease (PVD).
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 157
Sex: ALL
Minimum age (years): 33
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from EWMSC, Trinidad who presented with CLI.

Brief summary: The purpose of this study was to investigate limb salvage rates in patients with critical limb ischemia after endovascular revascularization.

Detailed description: A retrospective analytical study assessing limb salvage attempts and outcomes in 157 consecutive patients with CLI and tissue loss. It was for the period of May 2018 and May 2021 at Eric Williams Medical Sciences Complex.

The objectives of this study include Primary: To determine the success rate of target lesion revascularisation using endovascular limb salvage techniques in Critical limb ischemia patients with minor and major tissue loss.

Secondary objectives included:

1. to compare and contrast limb salvage rate to international standards
2. to assess the maintenance of amputation-free survival and bipedal ambulation
3. to evaluate the angiosome concept and its effect on wound healing
4. to evaluate primary patency rate
5. to assess the overall morbidity and mortality of endovascular treatment for critical limb ischemia
6. to observe the outcomes of various wound healing techniques and its efficacy

Eligibility criteria: Inclusion Criteria:

CLI patient with tissue loss who underwent infra inguinal endovascular limb salvage

Exclusion Criteria:

CLI patients with tissue loss who had surgical bypass CLI patients with no tissue loss

Primary outcomes:
measure: Primary outcome
timeFrame: 2 to 3 years
Secondary outcomes:
Other outcomes:
measure: Secondary Outcome
timeFrame: 2 to 3 years
measure: Co-Secondary Outcome
timeFrame: 2 to 3 years
Locations:
city: Port Of Spain
country: Trinidad and Tobago
facility: Eric Williams Medical Sciences Complex
state: North Central
Study officials:
References:
Clinical trial NCT05488522: SBRT With Atezo/Bev for HCC
Official title: A Phase I Study of SBRT Vaccination With Atezolizumab and Bevacizumab for Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I dose escalation and pharmacodynamic study of repeated dose stereotactic body radiotherapy (SBRT) administered with concurrent atezolizumab and bevacizumab for patients with advanced hepatocellular carcinoma (HCC)


Eligibility criteria: Inclusion Criteria:

* Subjects must have hepatocellular carcinoma (HCC) that is not amenable to curative-intent surgical or ablation (where surgery or ablation are not indicated due to disease extent, co-morbidities, or other technical reasons) and systemic therapy is indicated.

Exclusion Criteria:

-

Primary outcomes:
measure: Primary Objective
timeFrame: 3 years
Secondary outcomes:
measure: Secondary Objective
timeFrame: 3 years
measure: Overall Survival
timeFrame: 5 years
measure: Progression Free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center
name: Edgar Ben-Josef, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00427622: Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
Official title: A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Keywords: hot flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary.

PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as a way of measuring hot flashes in postmenopausal women with hot flashes.

Detailed description: OBJECTIVES:

* Correlate hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary in postmenopausal women with hot flashes.
* Determine the comfort, obtrusiveness, and feasibility of using the skin conductance recording tool for measuring hot flashes when worn daily for five weeks in these patients.

OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 5 weeks.

Patients complete hot flash diaries once daily for 5 weeks. Patients also complete the Comfort, Bother, and Weight Questionnaire at the end of week 5.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of bothersome hot flashes, defined by their occurrence of ≥ 4 times/day

  * Daily hot flashes have been present for ≥ 1 month

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* ECOG performance status 0-1
* No history of allergic or other adverse reactions to adhesives
* No other medical condition known to cause sweating and/or flushing
* Willing to record hot flashes in a hot flash diary daily for 5 weeks
* Willing to wear a skin conductance device 24 hours a day for 5 weeks
* No implanted pacemakers or metal implants
* No reliance on other electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary
measure: Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Debra Barton, RN, PhD, AOCN, FAAN
role: STUDY_CHAIR
References:
Clinical trial NCT02484222: Fentanyl Test in Children's Adenotonsillectomy
Official title: Fentanyl Test Results and Its Association With Morphine Requirements in Children With Obstructive Sleep Apnea Syndrome After Adenotonsillectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: adenotonsillectomy
fentanyl
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic nasopharyngoscope and underwent selective adenotonsillectomy

Brief summary: The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy；and to evaluate the ability of predicting requested dosage of morphine postoperatively.

Detailed description: All the patients were intubated. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. All the patients were given morphine for pain relief according to our protocol after extubation.

Eligibility criteria: Inclusion Criteria:meet all of the following

1. the American society of anesthesiologists (ASA) class Ⅰ \~ Ⅱ
2. the age of 3 \~ 7 years old
3. children who underwent selective adenotonsillectomy.

Exclusion Criteria:meet anyone of the following

1. craniofacial malformations
2. mental retardation
3. BMI \> 22 kg/m2
4. a history of bronchial asthma
5. a recent history of opioid use.

Primary outcomes:
measure: Rescue Morphine Requirement
timeFrame: average 1 hour from extubation
Secondary outcomes:
measure: Post-operative Nausea and Vomiting
timeFrame: average 1 hour from extubation
measure: Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent
timeFrame: average 1 hour from extubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chilren's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xuan Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li YH, Wang X, Zhou ZJ, Zhuang PJ. Association between fentanyl test results and rescue morphine requirements in children after adenotonsillectomy. J Anesth. 2018 Feb;32(1):77-81. doi: 10.1007/s00540-017-2433-0. Epub 2017 Nov 21.