louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03273777: Skin Incision Skewness at Cesarean Section
Official title: Comparison of Skin Incision Skewness With or Without Previous Measurement and Drawing of the Incision Line at Cesarean Section - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean section
Skin incision
Skewness
Line drawing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skin incision skewness, incision length on both sides of the midline and patient's perception of the scar after cesarean section will be compared between the following two groups: (1) Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.

Detailed description: Some aspects of the surgical techniques employed during cesarean section have already been evaluated in regards to possible improvements of cosmetic outcome, such as the use of different skin closure materials or whether subcutaneous fat suture closure leads to better results than non-closure. Another point to be considered is the skewness of the scar. Many surgeons make the skin incision based on their experience without prior measurement and drawing of an incision line. However, following a predefined incision line may reduce the rate of skew incisions. Therefore, this study aims to compare these two approaches to the skin incision.

Participating women will be recruited at the Department of Obstetrics and Gynecology of the Medical University of Vienna. They will be included into the study after written informed consent and will be randomized into one of the two groups (drawing of an incision line prior to skin incision versus no drawing of an incision line) on the day of cesarean section.

Skewness of the skin incision in each group will be assessed after cesarean section. Furthermore, it will be determined whether there are any differences in the incision length on both sides of an imaginary line from the umbilicus to the clitoris between these two techniques. Additionally, patient's perception of the scar before discharge from hospital will be assessed.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* First cesarean section

Exclusion Criteria:

* Performance of an acute cesarean section
* Previous cesarean section
* Body mass index \> 35 kg/m²

Primary outcomes:
measure: Skin incision skewness
timeFrame: 10 minutes (from a photograph taken at the end of the operation)
Secondary outcomes:
measure: Incision length on both sides of the midline
timeFrame: 2 minutes (1 minute for measurement at the end of the operation and 1 minute postoperatively from a photo taken at the end of the operation)
measure: Patient's perception of the scar
timeFrame: 1 minute (before discharge from hospital)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
Clinical trial NCT04317677: Effects of Bladder Voiding on Sleep Architecture in Infants
Official title: Effects of Bladder Voiding on Sleep Architecture in Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Sleep changes rapidly during the first year of life. Brain maturation is accompanied by sleep consolidation in several episode during day and night (daytime naps and night sleep) and progressive organization during the 24h period (more wake during day et more sleep during night). In the first months of life, sleep episodes are frequently interrupted by wake, possibly induced by multiple external and internal stimuli. One of this stimulus could be bladder voiding that is particularly frequent in babies. Only one team worked on the link between sleep and bladder voiding and reported that bladder voiding was associated with cortical arousal during a daytime nap in a little group of babies.

In this study, investigators propose to study the relationship between sleep and bladder voiding in a bigger group of infant and during daytime but also nighttime sleep.


Eligibility criteria: Inclusion Criteria:

* Infants of both sex
* Age ≥1 month and ≤ 12 months
* Referred to the sleep unit for sleep trouble screening following ALTE (Apparent Life Threatening Event).
* Patients should benefit from appropriate insurance system
* Parents who have expressed a willingness to participate in the study, who have signed and dated the informed consent.

Exclusion Criteria:

* Neurological, endocrinal or syndromic diseases :

  * Head and neck congenital malformations
  * Pierre Robin Syndrome
  * Trisomy
  * Achondroplasia
  * Prader Willy syndrome
  * Ondine syndrome
  * Cardiac diseases and malformations
* Weight \<2.5 kg
* Preterm babies (under 37 weeks of gestational age)

Primary outcomes:
measure: Occurrence of arousals / awakenings in a timely relation with bladder voiding.
timeFrame: 24 hours
Secondary outcomes:
measure: Sleep stage following bladder voiding events
timeFrame: 24 hours
measure: EEG frequencies following bladder voiding episodes
timeFrame: 24 hours
measure: Heart rate following bladder voiding episode
timeFrame: 24 hours
measure: Activity record with actigraphy in babies
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bron
country: France
facility: Service épilepsie, sommeil et explorations neuropédiatriques, Hôpital Femme mère enfant - Groupement hospitalier Est - HCL
Study officials:
References:
Clinical trial NCT02991677: Exercise Effect on Chemotherapy-Induced Neuropathic Pain
Official title: Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer, Breast
Cancer, Colorectal
Cancer, Lung
Cancer, Ovarian
Keywords: exercise
neuropathy
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
First posted: 2016-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.


Eligibility criteria: Inclusion Criteria:

* Diagnosis with cancer, stage I-IV
* History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
* Completion of chemotherapy \> 6 months \< 1 year
* Ability to walk on a treadmill
* Medical clearance from oncologist or primary care provider
* Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death)
* Score on Neuropathic Pain Scale \>1
* Age 21-70

Exclusion Criteria:

* Denial of CIPN
* Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
* Coronary artery disease
* History of \>1 chemotherapy regimen
* Musculoskeletal conditions which preclude participation in an exercise training program
* Pregnancy
* Regular exerciser, defined as \>90 minutes per week of aerobic exercise and any resistive training

Primary outcomes:
measure: Sensory pain
timeFrame: 13 weeks
Secondary outcomes:
measure: Nerve fiber density
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland at Baltimore School of Medicine
name: Alice Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947777: Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145
Official title: A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy subjects
DDI
CYP3A
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2013-09-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects

Detailed description: * In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
* In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin

Eligibility criteria: Inclusion Criteria:

* Healthy men or women of non-childbearing potential between 18-50 years of age
* Body Mass Index (BMI): 18.0 - 32.0 kg/m2
* In good health, determined by no clinically significant findings from clinical evaluations
* Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

* Women of childbearing potential
* Evidence of clinically significant medical conditions
* History of gastrointestinal disease or surgery that may affect drug absorption
* Positive or indeterminate Tuberculosis -spot test at screening
* Any active infection at the time of screening or admission
* Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge

Primary outcomes:
measure: Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656
timeFrame: Over 48 hours
measure: Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656
timeFrame: Over 48 hours
measure: Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656
timeFrame: Over 48 hours
measure: Plasma concentrations of IPI-145 and its metabolite, IPI-656
timeFrame: Over 48 hours
Secondary outcomes:
measure: Incidence of adverse events following administration of IPI-145, rifampin, and the combination.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA International, Inc
state: Kansas
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04168177: Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery
Official title: Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomly assigned into one of two groups, control group will receive patient controlled analgesia, and intervention group will receive ESP Block .
Primary purpose: PREVENTION

Brief summary: ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass


Eligibility criteria: Inclusion Criteria:

* elective surgery
* childern between 4 and 10 years

Exclusion Criteria:

* emergency
* infection at injection site
* allergy to local anaestheics

Primary outcomes:
measure: visual analogue score
timeFrame: 48 hours
Secondary outcomes:
measure: intraoperative anaesthetic consumption
timeFrame: 6 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT05239377: MiProstate - Information Hub for the Prostate Cancer Care Flow
Official title: Clinical Evaluation of the Benefits of the MiProstate Platform: Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Philips Electronics Nederland B.V. acting through Philips CTO organization
First posted: 2022-02-14
Enrollment: 1329
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients at Karolinska University Hospital in the time period Feb 2017- Mar 2019

Brief summary: This is an observational cohort study with a non-concurrent comparison group evaluating the use of a digital decision support tool (MiProstate/ISPM) at pre-prostatectomy, multidisciplinary conferences.

Detailed description: In the study cohort, all clinically relevant data on patients undergoing radical prostatectomy at Karolinska University Hospital were registered on the platform and subsequently presented using the platform at the conferences in which a detailed treatment plan was devised for each patient.

Eligibility criteria: Inclusion Criteria:

* All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital

Exclusion Criteria:

-

Primary outcomes:
measure: Efficiency - time spent in pre-operative conference
timeFrame: Recorded at pre-operative conference held <30 days prior to surgery
measure: Pre-operative conference quality
timeFrame: Recorded at pre-operative conference held <30 days prior to surgery
Secondary outcomes:
measure: PSM - positive surgical margin
timeFrame: At surgery. Reported within 30 days after surgery
measure: PROM1 - patient-reported outcome measure on urinary function
timeFrame: At 12 months post surgery (11-18 months is tolerated)
measure: PROM2 -patient-reported outcome measure on erectile function
timeFrame: At 12 months post surgery (11-18 months is tolerated)
measure: Nerve-sparing strategy
timeFrame: Recorded at pre-operative conference (<30 days prior to surgery)
measure: PLND - pelvic lymph node dissection strategy
timeFrame: Recorded at pre-operative conference (<30 days prior to surgery)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, Dept of Pelvic Cancer
name: Olof Akre, MD,Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753077: Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients referred from sleep center

Brief summary: Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward on upper airway is not completely known. In this study we will use both static and dynamic MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract at different mandible posits. Because in asian society non-obese OSA patients are not uncommonly seen, in this study we focus only on non-obese severe OSA patients.

Detailed description: The aim of this study is to analyze upper airway morphology changes and dynamic movement at different sections affected by mandible position by using dynamic and static magnet resonance imaging technique. The study also discusses the formation mechanism of obstructive sleep apnea syndromes and function mechanism of the oral appliance, as well as the evaluation of the clinical results of the oral appliance on non-obese male patients with severe obstructive sleep apnea in Taiwan.

10 non-obese (BMI\<25) severe OSA (AHI\>30) male patients between the age of 20 to 60 and 10 gender, BMI and age matched control (AHI\<5) were recruited for this study. Nine bite index were made for the different mandible positions of the subjects.

Upper airway was imaged by using static and dynamic MRI of each subject wearing the bite index while lying on the MRI scanning table. This study also measures the circumference and takes the lateral cephalometric imaging of each subject. Oral appliances were made and fitted for the experimental group subjects, who wore them for three months, after which they transferred to the Sleep Center and underwent PSG examination to evaluate therapeutic effects of the appliances.

Eligibility criteria: Inclusion Criteria:

* Severe obstructive sleep apnea (AHI\>=30/hr) age, sex, BMI match control subject

Exclusion Criteria:

* Patients were excluded when:

  * (1) refused to participate in this study,
  * (2) had severe obstructive pulmonary disease or active neurological events,
  * (3) enrolled in other studies at the same time

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: School of Dentistry, National Taiwan University
Study officials:
References:
Clinical trial NCT00707577: A Maintenance Program for the Be Fit Employee Wellness Program
Official title: A Randomized Controlled Trial of a Maintenance Program for the Be Fit Employee Wellness Program at Massachusetts General Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Worksite Wellness
Weight loss and maintenance
Physical Activity
Health and Fitness interventions
Healthy eating
Weight loss
Maintenance programs
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-01
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study is being done: 1) to determine if the MGH Be Fit program helps employees to change their nutrition and exercise habits and lower their risk for chronic diseases, such as heart disease and diabetes and 2) to determine if a maintenance program following the Be Fit 12 week program will help employees to keep the positive health changes.

Detailed description: The main objectives of this trial are to determine if employees who participate in the Be Fit 12 week program and are randomized to a 9 month maintenance program are more likely to maintain weight loss, physical activity level, and reduction of other clinical risk factors for disease compared to the control group. Secondary objectives are to determine if employees who participate in the maintenance intervention have fewer chronic diseases related to lifestyle factors and lower health care costs at 3 years.

Eligibility criteria: Inclusion Criteria:

* MGH (benefited) employees who enroll in the Be Fit program
* Able to commit to 1 year of active research participation

Exclusion Criteria:

* Not enrolled in the Be Fit program
* Decline participation in the research study
* Withdrawal from the Be Fit 12 week program prior to completion
* Women who are currently pregnant or suspect they may be pregnant
* Plans to leave MGH within 3 months from enrolling in Be Fit

Primary outcomes:
measure: Weight Loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne N Thorndike, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorndike AN, Sonnenberg L, Healey E, Myint-U K, Kvedar JC, Regan S. Prevention of weight gain following a worksite nutrition and exercise program: a randomized controlled trial. Am J Prev Med. 2012 Jul;43(1):27-33. doi: 10.1016/j.amepre.2012.02.029.
Clinical trial NCT04218877: The Factors Affecting Atopic Dermatitis in Children Age 1-3
Official title: Trigger's Influence on Atopic Dermatitis Manifestation in Children Under 3 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
Lead sponsor: Akusherstvo Pro
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients A Medclinic

Brief summary: This study evaluates the influence of different triggers on atopic dermatitis manifestation in children under 3 years old.

Detailed description: In this study investigators evaluate the influence of atopic dermatitis triggers before labour, right after labour, in firsts weeks after labour, in first year. Investigators want to find the most popular and most important factors witch provoke atopic dermatitis manifestation and comparison the results with children without atopic dermatitis but with genetic predisposition to it.

Eligibility criteria: Inclusion Criteria:

* children 1-3 age without rash, without atopic dermatitis
* children 1-3 age with recurrent atopic dermatitis

Exclusion Criteria:

* children 1-3 age with non-specific rush
* children age 1-2 with atopic dermatitis without rush during previous year

Primary outcomes:
measure: Trigger's factors for atopic dermatitis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Amedclinic
Study officials:
References: