louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03330951: Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers
Official title: Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Pregnancy
Keywords: HbA1c
Glycated albumin
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2017-11-06
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with pregestational diabetes mellitus

Brief summary: This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus.

Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).


Eligibility criteria: Inclusion Criteria:

* pregestational diabetes mellitus
* singleton pregnancy
* follow-up at Stavanger University Hospital in pregnancy

Exclusion Criteria:

* gestational diabetes
* twin pregnancies

Primary outcomes:
measure: Glycemic Control markers in pregnancy
timeFrame: throughout pregnancy, gestational week 12-36.
Secondary outcomes:
measure: Iron status in diabetic pregnancy,
timeFrame: throughout pregnancy, gestational week 12-36.
measure: Preterm delivery
timeFrame: at delivery.
measure: Preeclampsia
timeFrame: From gestational week 20 to 1 week after delivery.
measure: Induction of labour
timeFrame: At delivery.
measure: APGAR
timeFrame: At delivery.
measure: Birth weight
timeFrame: At delivery.
measure: Admission to neonatal intensive care unit
timeFrame: At delivery.
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Johanne Toft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734651: PROMIS Evaluation Study
Official title: Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthropathy
Osteoarthritis, Hip
Perthes Disease
Osteonecrosis
Femoral Neck Fractures
Lead sponsor: Bezirkskrankenhaus St. Johann in Tirol
Sponsor class: OTHER
Collaborators: name: Tyrolean Arthroplasty Registry
First posted: 2023-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated with primary total hip arthroplasty at this department are included.

Brief summary: A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.

The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.


Eligibility criteria: Inclusion Criteria:

* Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Stem Migration
timeFrame: 20 years
Secondary outcomes:
measure: WOMAC Score
timeFrame: 20 years
Other outcomes:
Locations:
city: Sankt Johann In Tirol
country: Austria
facility: BKH St. Johann in Tirol, Department for Orthopedics and Traumatology
state: Tyrol
Study officials:
References:
citation: Wagner M, Neururer S, Dammerer D, Nardelli P, Kaufmann G, Braito M, Brunner A. External validation of the Tyrolean hip arthroplasty registry. J Exp Orthop. 2022 Aug 30;9(1):87. doi: 10.1186/s40634-022-00526-3.
Clinical trial NCT03497351: Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries
Official title: Effects of Different Kinds of Antihypertensive Drugs on Dynamic Hemodynamic Changing of During Laparoscopic Gastrectomy and Laparotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Surgery
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: SVV is clinically affected by a variety of factors, such as abdominal pressure, body position, tidal volume, type and temperature of liquid treatment, etc. There are few reports on the effects of drugs on SVV.

In clinical anesthesia, surgical stimulation and stress can affect patient hemodynamic stability, used in intraoperative vascular active drug is inevitable, they shrink or dilate blood vessels, speed up or slow down the heart rate, makes the ventricular preload and corresponding changes in the SV. Now, there is a study on SVV and PPV in patients with hypertension, but there are few reports on the effect of blood pressure drugs on the changes in patients' threshold.


Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ-Ⅲ
2. body mass index (BMI) 18-26kg/m2.
3. Hypertension and non-hypertensive patients
4. diabetic no complications
5. no lung, liver, kidney and blood system diseases
6. preoperative examination is basically normal.

Exclusion Criteria:

* Any type of arrhythmia, intraoperative need for other vasoactive drug intervention.

Primary outcomes:
measure: SVV
timeFrame: The period between the begining of anesthesia and the end of operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Haidian
Study officials:
References:
Clinical trial NCT04636151: E-Manage: A Brief mHelath Intervention for University Students
Official title: E-Manage: A Brief mHelath Intervention for University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress, Emotional
Suicidal Ideation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2020-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a two-part transdiagnostic psychological intervention aimed to help people respond to negative emotion and emotional distress in more adaptive ways using a technology called "ecological momentary intervention" (or EMI) that delivers intervention content using a smartphone app. Participants in this study will be Rutgers students recruited through-or currently affiliated with - Counseling, Alcohol and Other Drug Assistance Program \& Psychiatric Services (CAPS) at Rutgers. Participants will first attend either one-on-one or group telehealth therapy sessions/workshops, where they will learn the therapeutic skills that are part of the study. Then, they will complete up to 8 weeks of smartphone monitoring that involves assessments and opportunities to practice the skills learned in therapy.


Eligibility criteria: Inclusion Criteria

* Age 18 years or older
* Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)
* Currently residing in US
* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
* iOS and Android smartphone compatible with MetricWire. Nearly all phones since 2014 are compatible

Exclusion Criteria

* Non-English speaking
* Unable to understand or provide informed consent

Primary outcomes:
measure: Change in momentary levels of self-reported distress
timeFrame: 8 week study period
Secondary outcomes:
measure: Change in momentary levels of suicidal thinking
timeFrame: 8 week study period
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Evan Kleiman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04658251: Study of New Mutations in Cone Disorders
Official title: Functional Study of Intronic Variants in Inherited Cone Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Dystrophy, Cone-Rod
Cone Dystrophy
Cone Rod Dystrophy
Macular Degeneration
Keywords: intronic variant
splicing
functional test
cone disorders
retinal dystrophy
RNA
minigene splice assay
cells
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients carrying an intronic variant of unknown significance (or carrying an exonic variant with a predicted effect on splicing) in a gene implicated (or potentially implicated) in cone disorders, will be included in the study.

Brief summary: High throughput sequencing gives the opportunity to improve the genetic diagnosis for patients suffering from retinal dystrophies and specially from cone disorders. However, a large number of mutations are identified, mostly in introns of the genes, and in silico analysis are not sufficient to assign the pathogenicity of these mutations, without which the diagnosis confirmation cannot be done. For that purpose, a functional analysis of intronic variants of unknown significance detected in patients, with minigene splice assays in parallel with the analysis of the effect of the variant on splicing directly in the cells of the patient, by analyzing the RNA from leucocytes, fibroblasts, lymphoblastoïd cells or precursor of photoreceptor cells, which is the only proof of pathogenicity for variants


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of cone disorder
* identification of a variant of unknown significance
* possibility of samplings
* informed consent

Exclusion Criteria:

* no variant of unknown significance identified
* no informed consent

Primary outcomes:
measure: Effect of the intronic variant on RNA splicing observed in cellulo and/or on patient cells,
timeFrame: at 2 years
Secondary outcomes:
measure: Effect of the intronic variant on RNA by Minigene splice assay in transient cell cultures
timeFrame: at 2 years
measure: Effect of the intronic variant on RNA by analysis of patient RNA transcripts
timeFrame: at 2 years
measure: Effect of the intronic variant on RNA by analysis of transcripts from fibroblasts
timeFrame: at 2 years
measure: Effect of the intronic variant on RNA by analysis of transcripts from lymphoblastoid lines
timeFrame: at 2 years
measure: Effect of the intronic variant on RNA by analysis of transcripts from IPSCs (induced pluripotent stem cells)
timeFrame: at 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Claire-Marie DHAENENS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02484651: Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?
Official title: Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade: a Randomized Controlled Study Assessing Propofol and Remifentanil Requirements and Quality of Recovery in Patients With a Standard Practice of Non-deep Rocuronium Neuromuscular Blockade Versus Deep Neuromuscular Blockade Reversed With Sugammadex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Block
Keywords: deep neuromuscular block
sugammadex
stability of anesthesia
suppression of EMG activity
PQRS
General Anesthesia
Quality of Recovery
Lead sponsor: Centro Hospitalar do Porto
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).


Eligibility criteria: Inclusion Criteria:

* Patients ASA I-III
* Between 18 - 80 years old
* Scheduled for routine cervical surgery
* Minimum duration of surgery is 90 minutes and performed with total intravenous anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the neuromuscular relaxant rocuronium
* Patients that are able to and do provide a signed informed consent form

Exclusion Criteria:

* Patients with neuromuscular diseases and severe cardiac and respiratory pathologies
* Contra indication for any of the drugs used
* Not able to complete the baseline PQRS test.
* Indication to perform tracheal intubation using fibroscopy
* Patients who are pregnant or nursing

Primary outcomes:
measure: BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia
timeFrame: Maintenance of anesthesia, an average of 130 minutes
measure: Required Effect-site Concentrations of Propofol and Remifentanil
timeFrame: Maintenance of anesthesia, an average of 130 minutes
Secondary outcomes:
measure: PQRS Results at 15 and 40 Minutes After Surgery (Taking Into Account the Patient Baseline Values of the PQRS Test Done on the Preanesthetic Visit)
timeFrame: 15 and 40 minutes after surgery
measure: PQRS Satisfaction Results at Day 3 After Surgery
timeFrame: 3rd day after surgery
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
Study officials:
affiliation: Centro Hospitalar do Porto
name: Pedro Amorim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03042351: Pilot Study for the Urinary Incontinence Treatment
Official title: Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Pelvic Floor
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
Collaborators: name: eCareYou Innovation
First posted: 2017-02-03
Enrollment: 36
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: Non invasive study to improve the urinary incontinence, through pelvic floor muscles exercises

Detailed description: A non invasive study to improve the urinary incontinence performed in 36 women from two groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor muscles exercises with a restorative pelvic floor device every day for two months using the Magic Kegel app download in their mobile devices

Eligibility criteria: Inclusion Criteria:

* Urinary incontinence diagnosis

Exclusion Criteria:

* No urinary infection
* No surgery for urinary incontinence

Primary outcomes:
measure: Changes in values registered in Magic Kegel App
timeFrame: Six months
Secondary outcomes:
measure: Changes in ICIQ-SF questionnaire at month 2 respect to baseline
timeFrame: 60 days
measure: Changes in FSFI questionnaire at month 2 respect to baseline
timeFrame: 60 days
measure: Changes in Sandvick questionnaire at month 2 respect to baseline
timeFrame: 60 days
measure: Changes in PISQ-12 questionnaire at month 2 respect to baseline
timeFrame: 60 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
affiliation: Instituto Palacios
name: Santiago Palacios, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757951: Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture
Official title: Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Trauma
Keywords: Ankle
Fracture
medial malleolus
Osteosynthesis
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 126
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.


Eligibility criteria: Inclusion Criteria:

* Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)
* Age: 16 years or older
* Voluntary
* Operated within 7 days of the trauma
* Able to walk unaided before the current trauma

Exclusion Criteria:

* Peripheral neuropathy
* Pilon fracture
* Bilateral ankle fracture
* Concomitant tibial fracture
* Pathological fracture
* Active infection around the ankle
* A previous ankle fracture on either side
* In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs
* Inadequate co-operation
* Permanent residence outside the catchment area of the study hospital

Primary outcomes:
measure: Olerud-Molander Ankle Score
timeFrame: 2 years
Secondary outcomes:
measure: The Foot and Ankle Outcome Score (FAOS)
timeFrame: 2 years
measure: A 100 mm Visual Analogue Scale for function and pain (VAS)
timeFrame: 2 years
measure: The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)
timeFrame: 2 years
measure: Talocrural joint congruence
timeFrame: At two, four and 12 weeks, and at 2 years
measure: Fracture healing
timeFrame: 2 years
Other outcomes:
measure: Complications and Harms
timeFrame: At two, four and 12 weeks, and at 2 years
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Pohjois-Pohjanmaan sairaanhoitopiiri
name: Harri J Pakarinen, MD, PhD, AP
role: STUDY_DIRECTOR
References:
Clinical trial NCT05388851: Education for Prevention of Melanoma in Hispanic Populations
Official title: Education for Prevention of Melanoma in Hispanic Populations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial is to develop an educational platform to educate and prevent melanoma in Hispanic populations. Melanoma is cancer arising in the skin. Educational platforms to increase the knowledge and practice of sun smart behaviors (sunscreen use, sun protective clothing use, self-skin examination) may help reduce risk of and incidence of melanoma and improve cancer survival.

Detailed description: PRIMARY OBJECTIVES:

I. Develop online education platform to educate the Hispanic community. II. Demonstrate improvement in knowledge and practice of sun smart behaviors. III. Determine if the education platform leads to increase visits to their medical provider and increase diagnosis of skin cancers, particularly melanoma, in our population.

OUTLINE:

Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training.

Eligibility criteria: Inclusion Criteria:

* Mayo Clinic patients who self-identify as Hispanic or Latino
* Age 18 and older
* Have an email on file with Mayo Clinic

Exclusion Criteria:

* All patients who do not meet inclusion criteria

Primary outcomes:
measure: Knowledge score after completing the educational module
timeFrame: Up to 3 months
Secondary outcomes:
measure: Knowledge score three months after completing the educational module
timeFrame: 3 months after completing education module
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Aaron R Mangold
role: PRINCIPAL_INVESTIGATOR
References: