louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06352489: Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia.
Official title: Posterior Component Separation in the Management of the Complex Ventral Hernia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall.
* Detect most common post operative complications related to AWR techniques in a 6 months duration after operation.

Detailed description: posterior component separation(PCS) is one of the surgical techniques used in abdominal wall reconstruction plan foe management of relatively complex ventral hernia ,which cannot be treated with the conventional surgical way.

With or without transverses abdominis release(TAR) technique, (PCS) became widely accepted as surgical technique specially for large sized hernia defect, previous multiple laparotomies or unhealth abdominal soft tissue.

This study has a primary outcome which is detection of recurrence rate in patients under went posterior component separation technique in a period of 6 month after operation.

Eligibility criteria: Inclusion Criteria:

* patients with complex ventral hernia with contraindication to the conventional surgical therapy.

Exclusion Criteria:

1. patients with contraindication to long standing anesthesia.
2. patients with emergency hernia situation.
3. pregnant patients.

Primary outcomes:
measure: Hernia recurrence
timeFrame: six month after operation
Secondary outcomes:
measure: post operative short term complications
timeFrame: One month after operation
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Samir A Ammar
role: STUDY_DIRECTOR
References:
citation: Ramirez OM, Ruas E, Dellon AL. "Components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990 Sep;86(3):519-26. doi: 10.1097/00006534-199009000-00023.
citation: Novitsky YW, Elliott HL, Orenstein SB, Rosen MJ. Transversus abdominis muscle release: a novel approach to posterior component separation during complex abdominal wall reconstruction. Am J Surg. 2012 Nov;204(5):709-16. doi: 10.1016/j.amjsurg.2012.02.008. Epub 2012 May 16.
citation: Kockerling F, Reinpold W, Schug-Pass C. [Abdominal wall hernias part 2 : Operative treatment techniques]. Chirurg. 2021 Aug;92(8):755-768. doi: 10.1007/s00104-021-01383-z. Epub 2021 Apr 1. German.
Clinical trial NCT06387589: Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain
Official title: Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain"

Detailed description: The purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas on Pain, physical function, lumbar ROM and Hip ROM in patients Non-Specific Low Back Pain" adults (age : 30-50 years )

1. Numeric pain rating scale
2. Goniometer
3. Inclinometer
4. Oswestry Disability Questionairre Data will be collected before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.

Eligibility criteria: Inclusion Criteria

* Gender: Both male and female
* Individuals aged 30-50 years
* Non-Specific low back pain for at least 3 months
* pain radiating no further than the buttock
* Pain range between 3-8 on NPRS
* Positive Thomas Test

Exclusion Criteria:

* Diagnosis of systemic metabolic and/or neurological disorder, neuromuscular disorders, pregnancy
* Patients who have been receiving any other physical therapy treatment for NSLBP in the same period of the interventions
* Patients having Low back pain with any specific cause

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
measure: Level of disability
timeFrame: 4 weeks
measure: Lumbar Range of motion
timeFrame: 4 weeks
measure: Hip Range of motion
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT00719589: Outcomes of Pudendal InterStim
Official title: Outcomes of Pudendal InterStim
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voiding Dysfunction
Keywords: Voiding Dysfunction
Interstim
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at William Beaumont Hospital-Royal Oak who have had implantation of an Interstim with a pudendal lead.

Brief summary: The purpose of this study is to determine how many patients who have failed treatment with a sacral lead can achieve good results with a pudendal, patients satisfaction with the results of each lead, complication rates after pudendal lead placement, and how many patients have required reprogramming of their device with EMG testing( a more costly procedure).

Detailed description: InterStim is a bladder pacemaker device that has been in use for over 10 years for patients with voiding dysfunction. Although standard of care is to place the lead at the sacral nerve, in some patients a better response is obtained by placing the lead at the pudendal nerve.

Data will be collected from the subjects medical records and a questionnaire will be mailed one time to assess patients perception of improvement and treatment satisfaction after pudendal Interstim.

Eligibility criteria: Inclusion Criteria:

* All patients having had Interstim with a pudendal lead at Beaumont

Exclusion Criteria:

* None

Primary outcomes:
measure: To determine the outcomes of pudendal interstim in terms of number of failed sacral lead patients that can be salvaged with a pudendal lead,
timeFrame: 2 years
Secondary outcomes:
measure: To determine the outcomes of pudendal interstim in terms of complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
Study officials:
affiliation: William Beaumont Hospital - Royal Oak
name: Kenneth M Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907889: FoodSEqual Food Study
Official title: FoodSEqual Food Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diet Habit
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: University of Plymouth
First posted: 2023-06-18
Enrollment: 400
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: General public

Brief summary: Diet is an important modifiable risk factor for many chronic diseases, but there is a paucity of dietary data from disadvantaged communities. The last Low Income Diet and Nutrition Survey (LIDNS) was conducted more than a decade ago and disadvantaged communities are known to be under-represented in other national surveys.

The aim of the study is to investigate diet and health and factors contributing to dietary choice in a sample of socio-culturally diverse disadvantaged communities using a combination of dietary intake assessment methods, including nutritional biomarkers

Detailed description: The FoodSEqual project is part of a five-year national consortium project led by the University of Reading and involves academics from Plymouth, Sussex, Kent and Cranfield Universities. It is funded by the UK Research and Innovation (UKRI) Strategic Priorities Fund (SPF). The vision of the FoodSEqual project is to provide citizens of socio-culturally diverse disadvantaged communities with choice and agency over the food they consume by co-developing new products, new supply chains and new policy frameworks that deliver affordable, attractive, healthy, and sustainable diet. The FoodSEqual Health project is a follow-on project to investigate associations between diet, health, and food affordability in the context of the FoodSEqual project.

Diet is an important modifiable risk factor for many chronic diseases, but there is a paucity of dietary data from disadvantaged communities. The last Low Income Diet and Nutrition Survey (LIDNS) was conducted more than a decade ago and disadvantaged communities are known to be under-represented in other national surveys.

The aim of the study is to investigate diet and factors contributing to dietary choice in a sample of socio-culturally diverse disadvantaged communities using a combination of dietary intake assessment methods, including nutritional biomarkers.

Eligibility criteria: Inclusion Criteria:

* 18 years and over

Exclusion Criteria:

* unable to provide consent

Primary outcomes:
measure: Food intake
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
Clinical trial NCT02605889: Acupuncture in the Complementary Treatment of Diabetes Mellitus Type II
Official title: Acupuncture in the Treatment of Diabetes Mellitus Supplemental Type II : Applied Clinical Intervention by Nurses Acupuncturists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 132
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical research, with triple blinded multicenter involving the Federal University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's Programme in Public Policy and Local Development.

As Research, the study covers health units of the Municipal Family Health Maricá / Rio de Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.

The object of investigation is the effectiveness of acupuncture in nursing care in complementary treatment of adult patients Diabetes Mellitus type II.

Detailed description: This study has the general objective to evaluate the effectiveness of acupuncture as a complementary treatment to medication used in patients with diabetes mellitus type II, based on the nursing diagnoses.

Eligibility criteria: Inclusion Criteria:

* Be in possession of Diabetes Mellitus Type II only
* It is undergoing treatment for at least 1 year properly prescribed (to be confirmed with the medication of revenue)
* Report difficulties in glycemic control, regular saving measures higher than recommended by the Brazilian Society of Diabetes (postprandial up to 180mg / dl)

Exclusion Criteria:

* Have a lower limb amputated or part of them (because of the location of the selected acupoints for the treatment protocol)
* Be insulin
* Being a smoker
* Be alcoholic
* Be in drug treatment for other diseases including obesity
* Be making specific diet for weight loss
* Practicing regular physical activity
* Be in possession of cancer
* Being pregnant

Primary outcomes:
measure: Improvement of blood postprandial glucose levels
timeFrame: six week
Secondary outcomes:
measure: Improvement of Nursing Diagnoses
timeFrame: six week
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Claudia Dayube Pereira
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Neide Alvim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02980289: DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Nausea
Emesis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced cancer, who have not received chemo- or radiotherapy in the last 4 weeks prior to screening, will be screened for nausea and/or vomiting following evaluation of the primary inclusion-/exclusion criteria. The patients can be located either in the hospital departments, at home or in a hospice.

Brief summary: The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.


Eligibility criteria: Inclusion Criteria:

1. Advanced cancer
2. Age ≥ 18 years
3. Ability to read and understand the forms required for the study
4. Life-expectancy more than 2 weeks.
5. Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)

Exclusion Criteria:

1. Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
2. Chemotherapy or radiation therapy within the last 4 weeks
3. Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MRI scan of the cerebrum is needed before inclusion
4. Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator
5. Pregnancy

Primary outcomes:
measure: 2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week
timeFrame: From baseline and at 1 week (5-9 days)
Secondary outcomes:
measure: Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week
timeFrame: 1 week (5-9 days)
measure: Nausea at screening from EORTC-QLQ-C15-Pal at baseline
timeFrame: At baseline
measure: Emesis at screening from EORTC-QLQ-C15-Pal at baseline
timeFrame: At baseline
measure: Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week
timeFrame: From baseline and at 1 week (5-9 days)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense Universityhospital
Study officials:
References:
Clinical trial NCT02986789: Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes
Official title: Evaluation of Impacts of Continuous Non-Invasive Intra-Operative Hemoglobin and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Surgery
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes for the surgical patient.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice) under general anesthesia.
* At least one finger available and accessible for performing non-invasive hemoglobin monitoring.

Exclusion Criteria:

* Patient has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors
* Procedures performed using robotics surgery
* Any patients with a known hemoglobinopathy
* Any patients undergoing Cardio-Pulmonary Bypass (CPB)
* Any patients who cannot be transfused or has refused consent for a blood transfusion
* Patients being treated by any artificial oxygen carriers within 30 days of hospital stay
* Patients being managed outside of an operating room in the participating centers, or in operating room with conditions not conducive to perform and complete the study procedures (including use of the hemoglobin monitoring device)
* Patients younger than 18 years old
* Patients who are pregnant
* Patients with cardiac arrhythmia
* Patients with tidal volume setting \< 6ml/kg
* Patients with PEEP \>= 10cm H2O
* Patients undergoing cardiac and/or any open chest procedures
* Emergency patients due to the foreseeable difficulty in consenting
* Patients deemed not suitable for study at the discretion of the Principal Investigator

Primary outcomes:
measure: Average Volume of Allogenic RBC Transfused Intra-operatively
timeFrame: Approximately 6-8 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02561689: SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents
Official title: SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Occlusal caries
Resin fissure sealant
Longevity
Effectiveness
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 248
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Occlusal caries is the main reason for restorative therapy in the young permanent dentition, but restorations have limited survival time and may also weaken the tooth. An intact fissure sealing is an effective preventive treatment of occlusal caries lesions and may be used therapeutically to arrest the caries progression. However, the major challenge with fissure sealants is the frequent need for re-treatments, mostly due to inadequate retention.

Purpose: To quantify the longevity and effectiveness of the 6 resin sealants used prophylactically and therapeutically in permanent molar teeth.

Study design: The study is carried out as a prospective, clinically controlled study with split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities in Denmark uses 2 of the 6 sealants. The treatments are examined clinically and radiologically after 1, 2, 3, and 5 years.

Detailed description: The choice of the two materials is randomized and carried out so that all materials are used equally frequent and with an even distribution between dentists and dental hygienists.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents 5-14 years of age
* Children with 2, 4, 6 or 8 molars assessed to be in need of prophylactic or therapeutic sealing
* The radiographic penetration of the occlusal caries lesion must be limited halfway through the dentin

Exclusion Criteria:

* In case the occlusal surface is restored with communication between the restoration and the included lesion
* Subjects with chronic diseases that could affect their caries pattern
* Pain in teeth

Primary outcomes:
measure: Longevity of 6 resin fissure sealants assessed by defined scoring system
timeFrame: 5 years
measure: Efficacy of 6 resin fissure sealants assessed by defined radiological scoring system
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dental Health Care in Denmark
Study officials:
affiliation: University of Copenhagen
name: Azam AB Bakhshandeh, PhD
role: STUDY_CHAIR
affiliation: University of Copenhagen
name: Vibeke VQ Qvist, Dr Odont
role: STUDY_CHAIR
References:
Clinical trial NCT03011489: Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
Official title: Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 14
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.

Detailed description: newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.

the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.

Eligibility criteria: Inclusion Criteria:

* Non-syndromic Infants with complete unilateral cleft lip and palate
* Infants less than 3 months of age
* Males and females.
* Infants with displaced alveolus
* Patients whose parents provided written consent for the study.

Exclusion Criteria:

* Patients above 3 months of age
* Syndromic, malnourished and systemically ill infants.
* Patients with bilateral cleft lip and palate.
* Incomplete Cleft lip.
* Medically compromised patients
* Patient's/guardians who will be unwilling to go through the PNAM therapy

Primary outcomes:
measure: Parents' satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Changes in Nasal morphology( Height, width, angulation of columella
timeFrame: 3 months
measure: Changes in Interlabial gab
timeFrame: 3 months
measure: Changes in Maxillary arch dimension
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Fatma Abdu Abdelsayed, professor
role: STUDY_DIRECTOR
References: