louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03591679: Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section
Official title: Role of Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section in Patients At Risk of Uterine Atony A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 1070
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients were recruited from women attending labor ward to undergo cesarean section.


Eligibility criteria: Inclusion Criteria:

* Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included:
* Maternal anemia (not less than 7 gm %).
* Macrosomic baby \>4kgs.
* Twin pregnancy and high order pregnancy.
* Polyhydramnios.
* Grand multipara.
* Previous history of atonic postpartum hemorrhage.
* Prolonged vaginal delivery.
* Emergency cesarean.
* Chorioamnionitis.

Exclusion Criteria:

* - Placenta previa.
* Patients with bleeding tendency (congenital or acquired)
* Ante-partum hemorrhage.
* Patients with no risk for uterine atony.

Primary outcomes:
measure: mean Blood loss after placental separation
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
citation: Samy A, Ali MK, Abbas AM, Wahab HA, Wali AA, Hussien AH, Mostafa M, Taymour MA, Ogila AI, Ahmad Y, Essam A, Mahmoud M. Randomized controlled trial of the effect of bilateral uterine artery ligation during cesarean among women at risk of uterine atony. Int J Gynaecol Obstet. 2020 Feb;148(2):219-224. doi: 10.1002/ijgo.13064. Epub 2019 Dec 10.
Clinical trial NCT05185479: Analysis of Adverse Events in Anesthesia Using Artificial Intelligence
Official title: Analysis of ADVerse evENTs in Anesthesia Using ARtificial IntelligencE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Reaction
Keywords: Allergic Reaction
Adverse events
Health database
Natural Language Processing
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 9559
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minors and adults having had an allergic reaction associated with care, and having had an adverse event reported by an anesthetist between January 01, 2009 and June 30, 2020

Brief summary: The interest of health databases in anesthesia is no longer to be demonstrated. The aim of this research was to develop a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis:

The main objective of the study was to identify what a "naïve" unsupervised model would discover based on Adverse Event (AE) descriptions. Our second goal was to identify apparently unrelated events whose combination could favor the occurrence of an AE


Eligibility criteria: Inclusion Criteria:

* Minors and adults having had an allergic reaction associated with care
* Having had an adverse event reported by an anesthetist between January 01, 2009 and June 30, 2020

Exclusion Criteria:

- Patient not meeting the inclusion criteria

Primary outcomes:
measure: Development of a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis.
timeFrame: Files analysed retrospectively from January 01, 2009 to June 30, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France
Study officials:
affiliation: Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France
name: Paul-Michel MERTES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612079: The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Sertindole
sensory gating
PPI
P50 suppression
CANTAB
Effect of Sertindole on sensory gating (P50 suppression)
on sensorimotor gating (PPI)
and cognition (CANTAB)
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Psychiatric University Hospital, Zurich
name: H. Lundbeck A/S
First posted: 2008-02-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.


Eligibility criteria: Inclusion Criteria:

* Age: 18-40
* Gender: male

Exclusion Criteria:

* Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above.
* Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II.
* Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above.
* ECG: QTc-interval \>450 msec.
* Systolic blood pressure \<100 mmHg
* Bradycardia (Hf \< 50/Min) und Arrhythmias
* Hypokalemia or Hypomagnesemia

Primary outcomes:
measure: Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
timeFrame: after placebo and and after medical treatment
Secondary outcomes:
measure: Cognitive performances
timeFrame: after placebo and and after medical treatment
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Psychiatry Hospital
state: ZH
Study officials:
affiliation: University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
name: Franz X. Vollenweider, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holstein DH, Csomor PA, Geyer MA, Huber T, Brugger N, Studerus E, Vollenweider FX. The effects of sertindole on sensory gating, sensorimotor gating, and cognition in healthy volunteers. J Psychopharmacol. 2011 Dec;25(12):1600-13. doi: 10.1177/0269881111415734. Epub 2011 Sep 2.
Clinical trial NCT03932279: Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Official title: Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous T Cell Lymphoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cutaneous T cell lymphoma, atopic dermatitis, and psoriasis and healthy individuals without any of these conditions will be enrolled at Northwestern Memorial Hospital Dermatology outpatient clinic.

Brief summary: Investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous T cell lymphoma patients and compare this to the microbiome of age and sex matched controls.


Eligibility criteria: Inclusion Criteria:

* Group 1: Patients with stage IA-IIA cutaneous T cell lymphoma
* Group 2: Patients with stage IIB and above cutaneous T cell lymphoma
* Group 3: Patients with CD30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma
* Group 4: Patients with plaque psoriasis with BSA\>5% on routine phototherapy per standard of care
* Group 5: Patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care
* Group 6: Healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous T cell lymphoma
* All Groups: subjects who are age 18-89 years of age at time of enrollment
* All Groups: Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443).

Exclusion Criteria:

* All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
* All Groups: Subjects who are unable to give consent
* Patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics
* We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Primary outcomes:
measure: Bacterial diversity index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Alan Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05087979: Use of Stable Airway Management Device in Monitored Anesthesia Care
Official title: Use of Stable Airway Management Device in Monitored Anesthesia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: monitored anesthesia care
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine if the Stable Airway Management device (SAM) is safe in maintaining the airway in a stable, non-obstructing position during anesthetic cases requiring monitored anesthesia care (MAC).

Detailed description: Patients undergoing monitored anesthesia care as part of a procedure will be invited to participate in the study.

The stable airway management (SAM) device is an investigational device used to hold patient's head and airway in a stable position during a MAC procedure. An investigational device means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, the SAM will be compared to the standard of anesthesia care which consists of supporting patient's head, neck, and shoulders with pillows and towels when placing them in the correct position for the procedure.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing MAC anesthesia in the supine position
2. Patients able to give informed consent

Exclusion Criteria:

1. Age \< 18 years
2. Less than 88% oxygen saturation on room air
3. Non-elective procedures
4. Case duration \> 180 minutes
5. Presence of a cervical spine injury, instability, or cervical spine collar
6. Patients with airway, facial, or other anatomy deemed inappropriate for SAM use by anesthesiologist
7. General anesthesia as primary anesthetic
8. Prisoners
9. Pregnant women

Primary outcomes:
measure: Total Apneic Events /Total Number Requiring Airway Manipulation
timeFrame: Up to 6 hours
measure: Number of Subjects Converted From MAC to General Anesthesia
timeFrame: Up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Visnal Yajnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830479: Study of Endoscopic Versus Open Surgery for Urinary Reflux
Official title: A Randomized Trial of Endoscopic vs. Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux: Surgical Treatment of Reflux: Endoscopic vs. Traditional CHoices (STRETCH) Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vesicoureteral Reflux
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 0
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.


Eligibility criteria: Inclusion Criteria:

* Age \<12 years
* Unilateral or Bilateral Primary VUR
* Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter
* Recommended for surgical correction of VUR by Urologist

Exclusion Criteria:

* Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR
* Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR)
* Ureterocele
* Periureteral diverticulum
* Complete duplication of duplex collecting system on side with VUR
* Prior ARS, either open or endoscopic, regardless of success or failure
* History of other prior urinary tract surgery other than circumcision
* Solitary functional kidney
* Congenital or acquired immunodeficiency
* Chronic renal insufficiency or renal failure

Primary outcomes:
measure: Resolution of VUR at 4 months
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT03841279: Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis
Official title: Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 100
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: The target population for this study will be patients with undifferentiated inflammatory arthritis or seronegative rheumatoid arthritis from the outpatient practice of the Division of Rheumatology in Rochester, MN.

Brief summary: MRI has been shown to be helpful in identifying patients who present with undifferentiated inflammatory arthritis who will develop RA within a one year follow up period. The absence of other clinically apparent symptoms often causes delays in diagnosis of RA. The use of the MRI in conjunction with the physical examination has the potential to reduce diagnostic delay. Earlier diagnosis would allow for earlier treatment implementation for better patient outcomes.


Eligibility criteria: Inclusion Criteria:

≥ 18 years old

Undifferentiated inflammatory arthritis suspected to be early RA (≥1 joint with synovitis and ≥1 other tender joint)

Symptom duration ≤1 year

Exclusion Criteria:

Unwillingness or inability to return to Mayo Clinic Rochester for research follow-up visits

Current or previous use of DMARDS

Taking ≥10 mg of prednisone a day

Contraindications to contract enhanced MRI

History of another definite autoimmune or inflammatory rheumatic disease

History of psoriasis

History of inflammatory bowel disease

Unsuitably as deemed by the principal investigator

Primary outcomes:
measure: Earlier Diagnosis of RA if MRI is utilized
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kerry Wright, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00401479: A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
Official title: An Exploratory Phase I Study in Healthy Volunteers of GI Transit Following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: GW427353
b3-Adrenergic Receptor Agonist
Irritable Bowel Syndrome (IBS)
pharmacokinetics
tolerability
gastrointestinal transit
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the emptying of the colon and increases total colonic transit time.


Eligibility criteria: Inclusion Criteria:

* Subjects with no evidence of current or past history suggestive of gastrointestinal disease or disorder or medical illness that could compromise interpretation of the study.
* no clinically significant laboratory results collected at the screening visit
* men: body weight greater than or equal to 50kg (110 lbs)
* women: body weight greater than or equal to 45kg (100 lbs)
* BMI between 18.5 - 35 kg/m2

Exclusion Criteria:

* Females who are nursing or pregnant.
* history of inflammatory bowel disease
* history of gastric ulcers within 12 months of signing the informed consent form
* tobacco users

Primary outcomes:
measure: colonic emptying rate by radiolabeled scintigraphy
timeFrame: throughout the study
Secondary outcomes:
measure: Safety and tolerability: ECG, vital signs, adverse events, clinical lab tests. Diary card collection of stool frequency Stool consistency and ease of passage Blood levels of GW427353
timeFrame: throughout the study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00667979: Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
Official title: A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-28
Enrollment: 264
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age
* ED \>/= 6 months
* Stable sexual relationship for \> 6 months

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics

Primary outcomes:
measure: Sexual encounter profile Question 3
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01171079: Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
Official title: Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Keywords: postoperative adhesion after thyroidectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-07-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* operable thyroid neoplasm

Exclusion Criteria:

* a history of previous neck surgeries or uncontrolled medical diseases such as hyperthyroidism, diabetes, and hypertension
* administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
Study officials:
References:
citation: Yigit O, Uslu Coskun B, Coskun H, Yilmaz B, Alkan S, Cinar U, Dadas B. Efficacy of anti-adhesive barriers in secondary thyroidectomy: an experimental study. Laryngoscope. 2004 Sep;114(9):1668-73. doi: 10.1097/00005537-200409000-00031.
citation: Yilmaz O, Genc A, Taneli F, Demireli P, Deliaga H, Taneli C. Assessment of the efficacy of absorbable adhesion barriers on dissection in esophagus operations. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):409-14. doi: 10.1016/j.ijporl.2006.11.010. Epub 2006 Dec 11.