louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06195774: Effect of Epidural Analgesia on Regional Lung Ventilation in Parturient Women as Assessed by Thoracic Impedance
Official title: Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy Complications
Atelectasis
Keywords: pregnancy
labor
at term
electric impedance tomography
pulmonary impedance
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include healthy pregnant patients that come for spontaneous or induced labor at the hospital's delivery room.

Brief summary: The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor.

Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.


Eligibility criteria: Inclusion Criteria:

* At-term pregnancy (at least 36 weeks)
* ASA class I-II

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Class III or more
* BMI\>35 before pregnancy
* Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil)
* Contraindication to epidural analgesia
* Pregnancy-related complications (including pre-eclampsia)
* Respiratory system diseases
* Severe psychiatric disorders
* Twin pregnancy
* Skin lesions in correspondence to the position of the Electric impedance tomography belt
* Pacemaker or Implantable Cardioverter Defibrillator (ICD)
* Language barrier

Primary outcomes:
measure: Regional lung ventilation (ROI 1-4)
timeFrame: "before" measurements will be taken just before applying lumbar epidural analgesia, and "after" measurements will be taken 5 minutes and ten minutes after starting lumbar epidural analgesia. Measurements take 10 minutes of continuous registration
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasmus University Hospital
state: Anderlecht
Study officials:
affiliation: Erasmus University Hospital
name: Laszlo Szegedi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03036774: Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before General Anesthesia
Official title: Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Gastric contents
Ultrasound
Diabetes
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18
* American Society of Anesthesiologists (ASA) classification 1 to 3
* Needed a general anesthesia for a programmed surgical intervention
* Respect of instructions of the pre-operative fasting;
* Affiliation to the social security;
* Consent form signed

Non inclusion Criteria:

* Pregnant or breastfeeding women
* Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum)
* Patients treated with a prokinetic treatment and / or a level 3 analgesic

Exclusion criteria

* Unfeasibility to ultrasound measurement of antral area
* Failure to observe fasting instructions

Primary outcomes:
measure: Number of patients with full stomach
timeFrame: one day
Secondary outcomes:
measure: Glycemia
timeFrame: one day
measure: Fast duration
timeFrame: one day
measure: Glycated hemoglobin
timeFrame: one day
measure: Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)
timeFrame: one day
measure: Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)
timeFrame: one day
measure: Intraoperative hypoxemia
timeFrame: one day
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rotschild
city: Paris
country: France
facility: AP-HP Hopital Tenon
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hôpital Tenon
name: Julien Rousset, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Foch
name: Marc Fischler, MD-PhD
role: STUDY_CHAIR
affiliation: HopitalTenon
name: Francis Bonnet, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00289874: Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
Official title: A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 421
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
* Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

* Patient cannot have any other acute or chronic pulmonary disorder

Primary outcomes:
measure: Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
timeFrame: Baseline and week 3
Secondary outcomes:
measure: Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period
timeFrame: Baseline and Week 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20. doi: 10.1080/02770900902847727.
Clinical trial NCT01143974: Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer
Official title: Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Locally Advanced Malignant Neoplasm
Keywords: progress free survival
response rate
safety
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2010-06-15
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective drug for advanced breast cancer. The combination of these two drug may have a synergy with each other in treatment of advanced breast cancer.

Detailed description: combination of pemetrexed and cisplatin to treat advanced breast cancer. Previous regimen no more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Resistant to enthracycle and taxanes
* Has measurable disease

Exclusion Criteria:

* Has more than 3 previous chemotherapy regimens

Primary outcomes:
measure: PFS (progression free survival)
timeFrame: 2 Years
Secondary outcomes:
measure: Safety
timeFrame: 2 years
measure: Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Binghe Xu, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06884774: Hemorrhoidectomy With or Without Lateral Internal Sphincterotomy in Management of Patients With Hemorrhoids
Official title: Hemorrhoidectomy With or Without Lateral Internal Sphincterotomy in Management of Patients With Hemorrhoids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Internal Sphincterotomy
Hemorrhoidectomy
Hemorrhoids
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids.

Detailed description: Hemorrhoidectomy is associated with postoperative pain, and no single surgical technique has been proven to reduce the pain significantly.

However, there are many drawbacks to such techniques, such as postoperative pain and constipation. The cause of this postoperative pain is multifactorial. Spasm of the internal anal sphincter (IAS) is one of the factors which is exposed and impinged after EH. Therefore, Lateral internal sphincterotomy (LIS) is a widely used adjunct treatment after EH, which can abolish spasms of the IAS and subsequently relieve postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years old.
* Both sexes.
* All patients indicated for surgical Hemorrhoidectomy (2nd, 3rd, and 4th degree piles).

Exclusion Criteria:

* Patients with 1st degree piles.
* Patients with piles plus fissure.
* Age above 70 years old
* Unfit for surgery.

Primary outcomes:
measure: Anal pain score
timeFrame: 4 weeks postoperatively
Secondary outcomes:
measure: Degree of incontinence
timeFrame: 48 hours postoperatively.
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT00092274: Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Official title: An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Lymphoma, Follicular
Keywords: Follicular Lymphoma
Non Hodgkin´s Lymphoma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory follicular lymphoma grade I-II
* Tumor verified to be CD20 positive
* CT scan showing demarcated lesions

Exclusion Criteria:

* Previous treatment with rituximab resulting in less than partial response
* Previous radioimmunotherapy
* Previous stem cell transplantation
* Received the following treatments within 4 weeks prior to entering this study:

  1. Anti-cancer therapy
  2. Glucocorticosteroids unless less than 10 mg prednisolone/day
  3. Radiotherapy
* Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
* HIV positivity
* Hepatitis B or hepatitis C
* Uncontrolled or chronic bacterial, fungal or viral infection
* Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
* WHO performance status of 3 or 4
* If you are participating in another trial with a different new drug 4 weeks before you enter this trial
* Current participation in any other clinical study
* Pregnant or breast-feeding women
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
References:
citation: Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
citation: Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008 Jun 15;111(12):5486-95. doi: 10.1182/blood-2007-10-117671. Epub 2008 Apr 4.
Clinical trial NCT03547674: Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy
Official title: Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral palsy_AFO-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, cross-sectional within-subjects comparison
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) in children and adolescents is frequently accompanied by gait abnormalities. Ankle-foot orthoses (AFO) have been suggested to improve the gait pattern. Compared to conventional AFO, modular AFO offer the opportunity to tune its response to the patient's gait characteristics and/or functional maturity. However, the evidence level is still small and AFO tuning is not yet established in clinical routine. The study will investigate individual tuning of custom-built ankle-foot-orthoses (AFO) using gait analyses


Eligibility criteria: Inclusion Criteria:

* Patients in outpatient treatment from the University Children's Hospital Basel (UKBB)
* Informed Consent provided as documented by signature
* Confirmed diagnosis of cerebral palsy
* Confirmed diagnosis of spastic equinus and/ or drop foot,
* Gait pathologies treated with conventional AFO
* Gross Motor Function Classification System (GMFCS) level I or II

Exclusion Criteria:

* Other neuromuscular diseases
* Previous surgical treatment to improve gait pathologies
* Injections of Botulinum toxin 6 month prior to study inclusion
* Inability or unwillingness to follow the procedures of the gait analysis

Primary outcomes:
measure: gait profile score (GPS)
timeFrame: at end of study, an average of 1 month
Secondary outcomes:
measure: Movement analysis profile (MAP)
timeFrame: at end of study, an average of 1 month
measure: spatio-temporal parameter
timeFrame: at end of study, an average of 1 month
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel Children's Hospital (UKBB)
Study officials:
affiliation: Universitäts-Kinderspital beider Basel (UKBB)
name: Erich Rutz, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroder JH, Barandun GA, Leimer P, Morand R, Gopfert B, Rutz E. Novel Modular Walking Orthosis (MOWA) for Powerful Correction of Gait Deviations in Subjects with a Neurological Disease. Children (Basel). 2023 Dec 26;11(1):30. doi: 10.3390/children11010030.
Clinical trial NCT05595174: Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations
Official title: Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations: A Prospective Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Accerleration of Tooth Movement
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of maxillary canine retraction using self-ligating brackets system assisted with micro-osteoperforations: A prospective controlled clinical study


Eligibility criteria: Inclusion Criteria:

* Both male and female patients between the age (14-20 y).
* Patients indicated for maxillary first premolar extraction.
* Angle's Class I bimaxillary, Class II Division 1 malocclusion (ANB \<5).
* Irregularity index \< 4 mm.
* No previous orthodontic treatment.
* Fully erupted dentition.

Exclusion Criteria:

* Patients not indicated for non-extraction approach.
* Prominent canine root (in labial cortical bone).
* History of systemic and medical illness that could interfere with OTM.
* Previous orthodontic treatment.
* Extreme skeletal class II occlusion (ANB \>5).
* Poor oral hygiene or periodontally compromised patient

Primary outcomes:
measure: effect of canine retraction
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar University
Study officials:
affiliation: Al-Azhar University
name: khaled sobhy abdelaziz, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abbing A, Koretsi V, Eliades T, Papageorgiou SN. Duration of orthodontic treatment with fixed appliances in adolescents and adults: a systematic review with meta-analysis. Prog Orthod. 2020 Oct 5;21(1):37. doi: 10.1186/s40510-020-00334-4.
Clinical trial NCT00617474: The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group
Official title: The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Transplantation, Kidney
Keywords: erythropoietin
kidney allograft survival
Recombinant Erythropoietin
erythropoietin (Epo)-induced protein 29, human
Lead sponsor: Labbafinejhad Hospital
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2008-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.


Eligibility criteria: Inclusion Criteria:

* Hb: \>8 and \<10 gr/dl
* Age: \>18 and \<55 years
* Cholesterol: \<300 mg/dl
* Triglyceride: \<400 mg/dl
* First Transplantation
* Protocol of Immunosuppression: CSA + MMF + Prednisolone
* Systolic BP: \<14
* Diastolic BP: \<9

Exclusion Criteria:

* History of specified cardiac disease
* Second Transplantation or more
* Hb: \<7gr/dl
* The patient needs to infusion of blood
* Evidence of local or systemic infection, at the time of EPO injection
* Presence of ATN / DGF after transplantation
* Presence of emergent hypertension
* High risk patients ( Like; PRA\>50%)
* Past history of hypersensitivity

Primary outcomes:
measure: We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival.
timeFrame: May,2008
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03039374: External Phase MRI in Diagnosis of OASI
Official title: The Use of External Phase Array MRI, 3D Endoanal Ultrasound, and Manometry in the Diagnosis of Obstetric Anal Sphincter Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Sphincter Injury
Obstetrics Trauma
Keywords: OASI
Faecal incontinence
Obstetric anal sphincter injury
MRI
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-02-01
Enrollment: 53
Sex: FEMALE
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: All patients older than 18 and a 3rd or 4th degree perineal tear observed during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility.

Brief summary: There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater.

The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.

Detailed description: See the attacher research plan for a more detailed description

Eligibility criteria: Inclusion Criteria:

Women with OASI

Exclusion Criteria:

Under 18

Primary outcomes:
measure: Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of surgery Turku University
name: Mikael Victorzon, prof.
role: STUDY_DIRECTOR
affiliation: Resident in Gastroenterological surgery
name: Jaan Kirss, MD
role: PRINCIPAL_INVESTIGATOR
References: