louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03495557: Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
Official title: Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Incisional Hernia
Keywords: Hernia
Cholecystectomy
Mesh fixation
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control will have simple closure while experimental group will have simple closure+mesh
Primary purpose: PREVENTION

Brief summary: A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.

Detailed description: Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Laparoscopic cholecystectomy
* Emergent/elective
* ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement

Exclusion Criteria:

* Conversion to laparotomy
* Emergent re intervention
* Immunosuppression
* Umbilical hernia

Primary outcomes:
measure: Umbilical trocar site hernia incidence
timeFrame: 3 years
Secondary outcomes:
measure: Seroma incidence
timeFrame: 6 months
measure: Hematoma incidence
timeFrame: 6 months
measure: Wound infection incidence
timeFrame: 6 months
measure: Pain presence
timeFrame: 6 months, 1 and 3 years
measure: Hospital discharge
timeFrame: 48 hours
measure: Operative time
timeFrame: 2 hours
measure: Return to regular activity
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 3 years
measure: Surgeon satisfaction
timeFrame: 3 years
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
Study officials:
affiliation: Hospital de Mataró
name: Ana Ciscar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03634657: EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn
Official title: Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure of Member of Staff to Medical Diagnostic X-Ray
Keywords: Scattered radiation
X-ray protection
Radiation in cath lab
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.


Eligibility criteria: Inclusion Criteria:

* indication for coronary angiography

Exclusion Criteria:

* none

Primary outcomes:
measure: Operator dose
timeFrame: Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center Mainz
state: Rheinland Pfalz
Study officials:
References:
citation: Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.
citation: Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial. BMJ Open. 2019 Jul 3;9(7):e029509. doi: 10.1136/bmjopen-2019-029509.
Clinical trial NCT02140957: Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
Official title: Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Intervention and Toddler Bottle Use
Keywords: Toddler Bottle Use
Educational Intervention
Pediatrics
Iron Deficiency
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 251
Sex: ALL
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Observational studies support an association between bottle feeding beyond 15 to 18 months of age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency, behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic households, choose to feed their children by bottle much beyond this age. Recognizing the need for further educational interventions for bottle feeding, the TARGet Kids! Research Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9 month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal was to determine whether an office-based, educational intervention for parents of 9-month-old children could reduce bottle use and iron depletion at 2 years of age.


Eligibility criteria: Inclusion Criteria:

* Children and their families who participated in The Applied Research Group for Kids (TARGet Kids!) pragmatic RCT

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Iron Depletion
timeFrame: Baseline, 2 years
Secondary outcomes:
measure: Current Bottle Use
timeFrame: 2 years
measure: Current Nighttime Bottle Use
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jonathon Maguire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04447157: The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
Official title: The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microspherophakia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 9
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective study was conducted on 9 patients (18 eyes) diagnosed with microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine from July 2016 to April 2020.

Brief summary: By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.


Eligibility criteria: Inclusion Criteria:

* Microspherophakia was diagnosed and lens diameter\<9mm;
* The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
* Lens dislocated into the anterior chamber;
* Lens dislocation caused elevated intraocular pressure (IOP);
* The lens contacted the corneal endothelium;
* Cataract;
* Corneal endothelial cell density\>1000/mm2;
* The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；
* There was possible improvement in postoperative visual acuity measured by retinometer.

Exclusion Criteria:

* The lens is centered and the position of the lens is stable;
* Glasses can correct the vision obviously;
* The reason for the elevated IOP was independent with the lens;
* A high possibility of corneal decompensation after surgery;
* Fundus function was poor and it is not expected to improve the vision after surgery;
* Combined with other ocular diseases which were not suitable for IOL implantation;
* Combined with a systemic disease that the patient cannot tolerate the surgery.

Primary outcomes:
measure: Visual function
timeFrame: 6 month postoperation
measure: Visual function
timeFrame: 6 month postoperation
measure: Intraocular pressure
timeFrame: 6 month postoperation
measure: PCIOL tilt degree
timeFrame: 6 month postoperation
measure: PCIOL decentration distance
timeFrame: 6 month postoperation
measure: Endothelial cell density
timeFrame: 6 month postoperation
measure: Anterior chamber depth
timeFrame: 6 month postoperation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06658457: Headache in Juvenile Onset Systemic Lupus Erythematosus
Official title: Investigation of Factors That May Affect Headache in Individuals With Juvenile Onset Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Juvenile Systemic Lupus Erythematosus
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include individuals ages 8 to 25 years who are receiving treatment for Juvenile Onset Systemic Lupus Erythematosus at a university hospital in Turkey, and meet the inclusion and exclusion criteria.

Brief summary: The aim of our study was to compare individuals with juvenile onset systemic lupus erythematosus with and without headache in terms of pain, pain catastrophizing behavior, demographic and individual disease-related factors that may affect headache and temporomandibular joint dysfunction.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Juvenile Onset Systemic Lupus Erythematosus by the Pediatric Rheumatology Clinic
* Being between the ages of 8-25,
* Having stable symptoms and medications
* Being willing to participate in the study

Exclusion Criteria:

* Patients with neuropsychiatric disorders not associated with Juvenile Onset Systemic Lupus Erythematosus (such as history of epilepsy, electrolyte imbalance, or medication side effects)
* History of headache before juvenile onset systemic lupus erythematosus diagnosis
* Presence of another concomitant rheumatic disease
* Having cognitive impairment to the extent of not being able to cooperate

Primary outcomes:
measure: McGill Melzack Pain Questionnaire
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Pain Catastrophizing Scale for Children
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Pain Catastrophizing Scale for Parents
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Fonseca Anamnestic Questionnaire
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Demographic and disease-related data
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT06646757: Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
Official title: Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ulcerative Colitis (UC)
Crohn Disease (CD)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.


Eligibility criteria: Inclusion Criteria:

1. Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score \> 35 26,27)
2. Able to consent, complete surveys, and participate in focus groups in English.

Exclusion Criteria:

1. No/low disability (IBD-DI \< 35) on the baseline survey
2. Inability or unwillingness to participate in the interventions
3. Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
4. Limited English proficiency (necessary because some interventions are currently only offered in English)

Primary outcomes:
measure: Change in IBD-related disability based on the validated IBD-Disability Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in IBD Self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06480357: A Giant Myelolipoma.
Official title: A Giant Myelolipoma, Management by Laparoscopy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Myelolipoma
Keywords: Benign, neoplasms, adrenal myelolipoma
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-06-28
Enrollment: 1
Sex: FEMALE
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 48 Year old Female

Brief summary: 48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size.

Detailed description: A 48-year-old female presented to our hospital with the following medical conditions: She denies smoking and drug addiction. Type 2 diabetes mellitus under treatment with metfomin, surgical history of abdominal hysterectomy and open cholecystectomy.

The patient started experiencing pain located in the left flank for 2 months, which was intermittent, yielded to the administration of analgesics, she denied hematuria and weight loss.

On physical examination, the abdomen was distended due to adipose tissue, normal bowel sounds were auscultated, and abdominal masses are not palpable.

She underwent a computed tomography (CT) scan. CT features in the anatomical site of the left adrenal gland, a well-defined ovoid tumor is observed, with heterogeneous content with areas of hypodense (5 HU), fat and calcification. It measures 90 x 69 x 92 mm. Upon application of contrast medium, the hypodense parts present enhancement up to 44 HU. (Fig. 1, 2). She was decided for surgical resection of the tumor via laparoscopic transabdominal approach. The surgery went well without any intraoperative and postoperative complications. She was discharged after day 3.

Eligibility criteria: Inclusion Criteria:

* Patient with myelolipoma

Exclusion Criteria:

* Patient without myelolipoma

Primary outcomes:
measure: Cure of the disease
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Mexican Institute Of Social Health
state: Yucatán
Study officials:
References:
Clinical trial NCT02082457: Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
Official title: Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Constipation
Keywords: Irritable Bowel Syndrome
Constipation
C-IBS
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 273
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. more than 18 years old
2. patients met with ROME III criteria for C-type IBS

Exclusion Criteria:

* pregnancy or lactation
* a history of surgery for gastrointestinal tract
* a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit
* inflammatory bowel disease or malignant tumor within 5 years of screening visit
* taking drugs that could have impact on efficacy assessment

Primary outcomes:
measure: Abdominal pain intensity & stool frequency responder
timeFrame: 12weeks
Secondary outcomes:
measure: subject global assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gang Nam Gu
country: Korea, Republic of
facility: Gang Nam Severance Hospital
state: Seoul
Study officials:
affiliation: Gang Nam Severance Hospital
name: Hyo jin Park, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977157: Alcohol Detection Via Bioimpedance Mesurements
Official title: Alcohol Detection Via Bioimpedance Mesurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Impedance cardiography
bioimpedance
spectroscopy
extracellular resistance
body composition
hemodynamics
alcohol
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male subjects

Brief summary: Examination if the bioimpendanz measurement can be used for the determination of the alcohol content in human blood.

Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and one blood test.

Detailed description: In this clinical trail it will be analyzed, if it is possible to assess the blood alcohol content (BAC) with the bioimpedance devices (SFB7, ImpediMed; Nicomo).

This technology is non-invasive an can be measured by using conductive electrodes, capacitive electrodes or inductive measurement systems.

The BIS-values will be compared with an official breathanalyzer (Alcotest 7110 Evidential MK III, Dräger, Lübeck, Germany).

Furthermore one blood sample will be taken and analyzed with the ADH method as the current gold standard at the end of the trail.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* able to give informed consent
* Inconspicuous laboratory and drug screening

Exclusion Criteria:

* electrophobica
* alcoholphobica, -allergy
* metallic ans / or electric implants
* underage persons
* interactively medication

Primary outcomes:
measure: Bioimpedance measurements
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Anaesthesiology, University Hospital Aachen
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Anaesthesiology ,Chair for Medical Information Technology Helmholtz Institute for Biomedical Engineering RWTH Aachen University
name: Michael Czaplik, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: