louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01617707: Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam
Official title: Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Alcoholism
Keywords: sedation
endoscopy
midazolam
propofol
chronic alcoholics
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. In recent years, propofol has been used safety and effectively in sedative GI endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI endoscopic procedures.


Eligibility criteria: Inclusion Criteria:

* age ≥ 20
* ECOG ≥ 2
* patient who consents to enroll the trial

Exclusion Criteria:

* age \< 20
* pregnant or lactating women
* American Society of Anesthesiology (ASA) physical status class V
* chronic pulmonary disease
* history of allergic to propofol
* history of complication of sedation endoscope
* liver failure or hepatic encephalopathy
* who didn't consented to enroll the trial

Primary outcomes:
measure: Satisfaction of endoscopists, nurses and patients
timeFrame: about 5 minutes after the end of the procedure
Secondary outcomes:
measure: completion rate of endoscopy
timeFrame: about 5 minutes after the end of procedure
measure: number of participants with complications
timeFrame: participants will be followed during the procedure and recovery time, an expected average of 20 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT01203007: Diet Intervention in Food Sensitive Patients With IgA Nephropathy
Official title: A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IGA Nephropathy
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: Haukeland University Hospital
name: Smerud Medical Research International AS
First posted: 2010-09-16
Enrollment: 40
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 study is to assess whether a tailored diet, eliminating antigens to which IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.


Eligibility criteria: Inclusion Criteria:

* Above 18 years
* IgA nephropathy (IgAN), verified by biopsy
* Proteinuria \> 1 g/24 h
* Having signed informed consent form

Exclusion Criteria:

* Participation in another clinical trial
* Patients with celiac disease
* Introduction of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) during the last three months prior to inclusion
* Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months

Primary outcomes:
measure: Proteinuria
timeFrame: 6 months
Secondary outcomes:
measure: Renal function
timeFrame: 6 months
measure: IgA/IgG immune complexes, incl. glycosylation
timeFrame: 6 months
measure: IgA/IgG to dietary antigens
timeFrame: 6 months
measure: Hematuria
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Hilde K Smerud, MScPharm
role: STUDY_DIRECTOR
References:
Clinical trial NCT02409407: Misoprostol Before Hysteroscopy in Infertile Cases
Official title: Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention. It is currently acknowledged as the 'gold standard' investigation of the intrauterine abnormalities.

Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force needed for dilation, thereby potentially reducing the probability of procedural complication such as uterine perforation, cervical laceration, failure to dilate, and creation of a false track that can occur during cervical entry.

Misoprostol is a prostaglandin El analogue, that can be administered either orally or vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis of proteoglycans.


Eligibility criteria: Inclusion Criteria:

* Female patients aged from 20 to 40 years old.
* They are complaining with primary or secondary infertility.
* They undergo investigations including husband semen analysis, hormonal assay, U/S, Hystrosalpingography.

Exclusion Criteria:

* Known sensitivity to misoprostol.
* Any systemic disease contraindicating the use of prostaglandins (cardiovascular disease, hypertension, renal failure, etc).
* Concomitant neurologic disease that could affect the correct evaluation of pain.
* Pregnancy.
* Any contraindication to hysteroscopy such as Pelvic inflammatory disease (PID).
* Heavy uterine bleeding.
* Any uterine abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

Primary outcomes:
measure: level of pelvic pain according to a 10-point visual analogue scale (VAS)
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el Ainy hospital
Study officials:
affiliation: Kasr El Aini Hospital
name: Yomna A Bayoumi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03103607: Disappearance of Graves' Orbitopathy
Official title: Evaluation of the Disappearance of Graves' Orbitopathy in the Long Term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Eye Disease
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with GO

Brief summary: There is a general belief among physicians involved with Graves' orbitopathy (GO) that this syndrome is somehow "chronic", namely that the patient's eyes do not return the way they were before GO appeared.

The general impression that comes from the available studies is that the eyes of GO patients do not return to normal even after a very long time since the disease appearance under the physician's point of view, although a discrete proportion of patients feel so. However, no studies are available in which the issue was examined with both objective criteria and self-assessment.

The present study design was to investigated the disappearance of GO, regardless to treatment, in all consecutive patients with a history of GO of at least 10 years who came for a follow-up visit to our GO clinic over a period of 5 years.


Eligibility criteria: Inclusion Criteria:

* All GO patients with a GO history of at least 10 years who came for a follow-up visit in our GO clinic over a period of 5 consecutive years

Exclusion Criteria:

* None

Primary outcomes:
measure: Disappearance of GO
timeFrame: up to 18 years
Secondary outcomes:
measure: Objective disappearance of GO
timeFrame: up to 18 years
measure: Subjective disappearance of GO
timeFrame: up to 18 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02869607: Institut Paoli Calmettes Breast Cancer Database
Official title: Institut Paoli Calmettes Breast Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Diagnosis
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 45000
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: Patients with a diagnosis of Breat Cancer

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with breast cancer


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of breast cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Survival of patients with breast cancer
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhone
Study officials:
References:
citation: Houvenaeghel G, de Nonneville A, Cohen M, Chopin N, Coutant C, Reyal F, Mazouni C, Gimbergues P, Azuar AS, Chauvet MP, Classe JM, Darai E, Martinez A, Rouzier R, de Lara CT, Lambaudie E, Barrou J, Goncalves A. Lack of prognostic impact of sentinel node micro-metastases in endocrine receptor-positive early breast cancer: results from a large multicenter cohort☆. ESMO Open. 2021 Jun;6(3):100151. doi: 10.1016/j.esmoop.2021.100151. Epub 2021 May 10.
Clinical trial NCT01632007: Double-blind Comparative Study of SYR-472
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 245
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Akita-shi
country: Japan
state: Akita
city: Matsudo-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Fukuyama-shi
country: Japan
state: Hiroshima
city: Ishikari-shi
country: Japan
state: Hokkaido
city: Nakagawa-gun
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Naka-shi
country: Japan
state: Ibaragi
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kashiwara-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Arakawa-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Katsushika-ku
country: Japan
state: Tokyo
city: Mitaka-shi
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Shunan-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Inagaki N, Onouchi H, Maezawa H, Kuroda S, Kaku K. Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study. Lancet Diabetes Endocrinol. 2015 Mar;3(3):191-7. doi: 10.1016/S2213-8587(14)70251-7. Epub 2015 Jan 19.
Clinical trial NCT05256407: Digital Support for Parents of Children in Child Health Care
Official title: Digital Support for Parents of Children in Child Health Care - an Evaluation of an Intervention in Primary Health Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Children, Only
Health Care Seeking Behavior
Health Knowledge, Attitudes, Practice
Nurse-Patient Relations
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Västernorrland County Council, Sweden
First posted: 2022-02-25
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective case/control intervention study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Becoming a parent is a life-changing event that can be both gratifying and stressful. As a parent, one is responsible for another person, where there sometimes is a need for new information, knowledge, and advice to live up to the new requirements that a changing family situation requires. The objective of this study is to develop and evaluate a new digital channel in child health care for support of parents in child health care issues with particular focus on eHealth literacy and satisfaction with care. An intervention is planned to run over eight months and will be evaluated in an intervention- and control group (from another health care centre) at baseline, 4 months and at 8 months follow-up. Data includes interviews and questionnaires about parental stress and eHealth literacy as well as satisfaction with care. Data will be analysed with qualitative and statistical methods. Expected outcomes is reduced parental stress and increased satisfaction with child health care.


Eligibility criteria: Inclusion Criteria:

\* Swedish speaking parents with children (0-6 years) in Swedish child health care

Exclusion Criteria:

* Parents who are registered at an address other than their child
* Parents younger than 16 years

Primary outcomes:
measure: Parental Stress Scale
timeFrame: Parental stress at baseline
measure: Parental Stress Scale
timeFrame: Change Parental stress at 4 months
measure: Parental Stress Scale
timeFrame: Change Parental stress at 8 months
Secondary outcomes:
measure: eHealth Scale
timeFrame: eHealth literacy at baseline
measure: eHealth Scale
timeFrame: Increased eHealth literacy at 4 months
measure: eHealth Scale
timeFrame: Increased eHealth literacy at 8 months
Other outcomes:
measure: VAS Scale
timeFrame: Satisfaction with child health care at baseline
measure: VAS Scale
timeFrame: Satisfaction with child health care at 4 months
measure: VAS Scale
timeFrame: Satisfaction with child health care at 8 months
Locations:
city: Örnsköldsvik
country: Sweden
facility: Region Västernorrland
Study officials:
References:
Clinical trial NCT00364507: Serum Levels of Insulin- Like Growth Factor and Fertility
Official title: Serum Levels of Insulin-Like Growth Factor in Fertile and Infertile Women Over 40 Years Old
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: this study will try to determine whether serum levels of insulin like growth factor are higher in fertile women than infertile women.

Detailed description: this study will try to determine whether serum levels of insulin like growth factor are higher in fertile women than infertile women.The women will over 40 years old.

Eligibility criteria: Inclusion Criteria:

* 40-55 years old
* healthy

Exclusion Criteria:

* pregnant women
* breast feeding
* menopause
* vegetarian

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Orginization
name: David MANKUTA, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04511507: CytoSorb in Patients With Liver Failure
Official title: Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Liver Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Dysfunction
Lead sponsor: Institutul Clinic Fundeni
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 35
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: - patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines. The decision of hemoadsorption is made by the attending physician prior to study inclusion.

Brief summary: Hemoadsorption has been demonstrated to improve liver functional tests in patients with liver failure. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with acute liver failure, on liver functional tests, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.


Eligibility criteria: Inclusion Criteria:

* patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines

Exclusion Criteria:

* unsigned informed consent
* duration of therapy under 12 hours
* death before the three consecutive sessions

Primary outcomes:
measure: 30 days mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
Study officials:
affiliation: Fundeni Clinical Institute
name: Dana Tomescu, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00467207: Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function
Official title: Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2007-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to gain more knowledge about the association between muscle weakness, spasticity and motor control in children with cerebral palsy, and its relationship to hand function.


Eligibility criteria: Inclusion Criteria:

* Diagnosed spastic hemiplegic or diplegic cerebral palsy, reduced handfunction.
* Indication for treatment with Botulinum Toxin A
* Score 3 on House Classification of Upper-Extremity Functional Use
* Score 3 or better on Manual Ability Classification System

Exclusion Criteria:

* surgery within the last two years
* Treatment with Botulinum Toxin within the last six months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Torarin I Lamvik, md
role: STUDY_CHAIR
affiliation: Norwegian University of Science and Technology
name: Karin Roeleveld, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elvrum AK, Braendvik SM, Saether R, Lamvik T, Vereijken B, Roeleveld K. Effectiveness of resistance training in combination with botulinum toxin-A on hand and arm use in children with cerebral palsy: a pre-post intervention study. BMC Pediatr. 2012 Jul 2;12:91. doi: 10.1186/1471-2431-12-91.
citation: Braendvik SM, Elvrum AK, Vereijken B, Roeleveld K. Relationship between neuromuscular body functions and upper extremity activity in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e29-34. doi: 10.1111/j.1469-8749.2009.03490.x. Epub 2009 Oct 7.
citation: Braendvik SM, Roeleveld K. The role of co-activation in strength and force modulation in the elbow of children with unilateral cerebral palsy. J Electromyogr Kinesiol. 2012 Feb;22(1):137-44. doi: 10.1016/j.jelekin.2011.10.002. Epub 2011 Nov 8.