louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04638023: Arabin Pessary in Singleton Pregnancy
Official title: Arabin Pessary Use in Women at High Risk for Preterm Birth: 7 Years' Experience in a Single Tertiary Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Previous Mid Trimester Miscarriage
Previous Preterm Birth
Previous Cervical Surgery
Short Cervix on Ultrasound
Keywords: Arabin pessary, spontaneous preterm birth
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women high risk for spontaneous preterm birth who were managed with Arabin pessary were included.

Brief summary: This was a retrospective study sharing the experience of women high risk for spontaneous preterm birth managed by Arabin pessary.

Detailed description: The study recruitment was from 1st January 2013 until 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine ultrasound. The primary outcome measure was birth before 34 weeks gestation.

Eligibility criteria: Inclusion Criteria:

* all women high risk for spontaneous preterm birth

Exclusion Criteria:

* had Arabin insertion elsewhere
* delivered elsewhere
* incomplete record

Primary outcomes:
measure: Birth at or more than 34 weeks
timeFrame: From insertion of the Arabin pessary until birth of the foetus
Secondary outcomes:
measure: Type of labour
timeFrame: From insertion of the Arabin pessary until birth of the foetus
measure: Mode of delivery
timeFrame: From onset of labour until birth of the foetus
measure: Median birth weight
timeFrame: At birth
measure: Admission into neonatal intensive care unit
timeFrame: At birth until discharged from the hospital
measure: Mean cervical length
timeFrame: At insertion of the Arabin pessary
measure: Subsequent management
timeFrame: From insertion of Arabin pessary until birth of the foetus
measure: Combination with progestogen therapy
timeFrame: from insertion of Arabin pessary until birth of the foetus
measure: Complications
timeFrame: From insertion of Arabin pessary until birth of the foetus
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: National University of Malaysia
state: Kuala Lumpur
Study officials:
affiliation: UKM
name: Rahana Abd Rahman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahman RA, Atan IK, Ali A, Kalok AM, Ismail NAM, Mahdy ZA, Ahmad S. Use of the Arabin pessary in women at high risk for preterm birth: long-term experience at a single tertiary center in Malaysia. BMC Pregnancy Childbirth. 2021 May 10;21(1):368. doi: 10.1186/s12884-021-03838-x.
Clinical trial NCT03399123: Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
Official title: Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss
Keywords: Laparoscopic hepatectomy
Low tidal volume
Blood loss
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different tidal volume are conducted on the participant base on the randomized choices
Primary purpose: PREVENTION

Brief summary: To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

Detailed description: Background \& Aims:Liver cancer is an disease that threatening human health .Laparoscopic hepatectomy is more and more widely used.It is very important to reduce the bleeding during laparoscopic hepatectomy.The investigators found that low tidal volume can effectively reduce intraoperative bleeding.The aim of this study was to explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

Eligibility criteria: Inclusion Criteria:

1. Aged from 18 to 70 years old;
2. American association of anesthesiologists(ASA) score I to III;
3. Ability to adhere to the study schedule;
4. Ability to provide informed consent and complete all study assessments;
5. Patients undergoing selective surgery of laparoscopic hepatectomy.

Exclusion Criteria:

1. The New York Heart Association classification(NYHA) III to IV;
2. Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery.
3. BMI\>32Kg/m2;
4. Abnormal in blood coagulation function;
5. Patients with mental disease;
6. Patients with neuromuscular disease;
7. Concurrent enrollment in another Randomized controlled trial(RCT);
8. Absence of written informed consent.

Primary outcomes:
measure: Blood loss
timeFrame: through study completion, an average of 48hours
Secondary outcomes:
measure: central venous pressure
timeFrame: During operation
measure: mean arterial pressure
timeFrame: During operation
measure: oxygenation index
timeFrame: During operation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Zheng ShuGuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00493623: BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
Official title: A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-06-28
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women or men \>30 years of age;
* osteoporosis;
* vertebral osteoporotic fracture in past 4 weeks;
* fracture-related pain requiring analgesic treatment.

Exclusion Criteria:

* non-menopausal women;
* current treatment with another bisphosphonate;
* current treatment with class III analgesics.

Primary outcomes:
measure: Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
timeFrame: Day 7
Secondary outcomes:
measure: Percentage of patients with >=50% diminution of pain between day 0 and 7
timeFrame: Day 7
measure: Pain control
timeFrame: Day 7 and 1 month
measure: Analgesic medication
timeFrame: 1 month
measure: Hospitalization
timeFrame: 1 month
measure: AEs and laboratory parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Amiens
country: France
city: Angers
country: France
city: Bonneville
country: France
city: Bordeaux
country: France
city: Caen
country: France
city: Cannes
country: France
city: Clermont-ferrand
country: France
city: Echirolles
country: France
city: Lille
country: France
city: Lomme
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nantes
country: France
city: Nice
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint-priest En Jarez
country: France
city: Toulouse
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02230423: Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome
Official title: Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empty Nose Syndrome
Keywords: Functional nasal surgery
Empty Nose Syndrome (ENS)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel).

Detailed description: The aim of this study is to find out wether patients with high trigeminal perception threshold (=decreased intranasal sensibility) and low expression of TRP channels of the mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the identification of prognostic factors and therefore prevention of nasal surgery with bad outcome.

Further, differences between patients with empty nose syndrome and asymptomatic patients after extended intranasal surgery, concerning trigeminal perception and TRP channel expression will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a primary septoplasty and/or turbinoplasty
* Patients suffering from empty nose syndrome after measurably successful nasal surgery
* Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor patients)

Exclusion Criteria:

* Patients with known neurologic disorders that could compromise perception threshold measurements
* Patients with known allergies/intolerance to test agents that are used to measure perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)
* Inability to judge or understand the testing or the informed consent

Primary outcomes:
measure: Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression
timeFrame: Up to 1 year post-surgery
Secondary outcomes:
measure: Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery
timeFrame: Up to 1 year post-op
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
affiliation: Zurich University Hospital
name: Michael Soyka, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04060823: Implementing a Healthcare Provider Education Intervention in Rural Communities to Reduce Asthma Morbidity
Official title: Implementing a Healthcare Provider Education Intervention in Rural Communities to Reduce Asthma Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 512
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to pilot test the implementation of healthcare provider education interventions to improve asthma outcomes in rural youth residing in Bradford County, Florida. The investigators propose to assess the feasibility and acceptability of implementing the Easy Breathing program a rural, medically underserved county and evaluate changes in healthcare provider practices and asthma-related outcomes of rural youth diagnosed with asthma.


Eligibility criteria: Inclusion Criteria:

* Any child between 6 months and 18 years of age at one of the primary care clinics in Braford county.

Exclusion Criteria:

* Unable to meet inclusion criteria.

Primary outcomes:
measure: Change in child asthma diagnosis rates
timeFrame: Baseline up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Starke
country: United States
facility: Bradford County Health Department
state: Florida
city: Starke
country: United States
facility: Shands Starke Medical Group
state: Florida
city: Starke
country: United States
facility: Southside Elementary School
state: Florida
city: Starke
country: United States
facility: Starke Elementary School
state: Florida
Study officials:
affiliation: University of Florida
name: David A Fedele, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01168323: Spaced Education to Optimize Prostate Cancer Screening
Official title: Spaced Education to Optimize Prostate Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Medical Education
Educational Technology
Clinical Practice Guideline
Prostate specific antigen
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Agency for Healthcare Research and Quality (AHRQ)
name: American Urological Association
name: Astellas Pharma US, Inc.
name: National Institutes of Health (NIH)
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2010-07-23
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Two memory research findings (the spacing and testing effects) can dramatically improve retention of learning, but they have largely have been ignored by educators. The researchers have developed a novel form of online education (termed 'spaced education') based on these two effects which has been shown in randomized trials to improve knowledge acquisition and boost learning retention. Using prostate cancer screening as an experimental system, the researchers investigated whether spaced education could durably improve clinicians' behaviors, not just their knowledge.


Eligibility criteria: Inclusion Criteria:

* Primary care providers (physicians, nurse practitioners, and physician assistants) from the 8 Veterans Affairs (VA) hospitals in the New England region (Veterans Integrated Service Network 1 \[VISN-1\]) were eligible to enroll.

Exclusion Criteria:

* Primary care providers (PCPs) who ordered PSA as a screen for prostate cancer less than 10 times each year were excluded.

Primary outcomes:
measure: Percentage of inappropriate prostate-specific antigen (PSA) screening performed by clinicians
timeFrame: Weeks 1-108
Secondary outcomes:
measure: Change in test scores between cohorts measured in weeks 1-36
timeFrame: Weeks 1-36
measure: Change in spaced education performance measured in weeks 1-36
timeFrame: Weeks 1-36
measure: Clinicians' intention to participate in future spaced education programs
timeFrame: Week 36
measure: Time required by clinicians to complete the spaced education questions-explanations
timeFrame: Week 36
Other outcomes:
Locations:
city: Boston
country: United States
facility: Veterans Affairs Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System, Harvard Medical School
name: B. Price Kerfoot, MD EdM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerfoot BP, Lawler EV, Sokolovskaya G, Gagnon D, Conlin PR. Durable improvements in prostate cancer screening from online spaced education a randomized controlled trial. Am J Prev Med. 2010 Nov;39(5):472-8. doi: 10.1016/j.amepre.2010.07.016.
Clinical trial NCT01580423: The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing
Official title: The Role of Substance P on Perception of Breathlessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: dyspnea
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Substance P is released from sensory nerves and transmits pain information into the central nervous system. As pain and dyspnea share many characteristics, including similar neurological pathways, it is possible that substance P may contribute to the sensation of dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary disease (COPD) will provide lower ratings of breathlessness during resistive load breathing with oral aprepitant, a medication that blocks the activity of substance P, compared with placebo.


Eligibility criteria: Inclusion Criteria:

* 50 years of age or older
* diagnosis of COPD
* former smoker \> 10 pack-years
* clinical diagnosis of chronic bronchitis
* post-bronchodilator forced expiratory volume in one second (FEV1) 30 - 80% predicted
* FEV1/forced vital capacity ratio less than or equal to 70%

Exclusion Criteria:

* current smoker
* pregnant women
* concomitant disease that might interfere with study procedures
* peripheral vascular disease or cold hypersensitivity
* drugs that might interfere with aprepitant

Primary outcomes:
measure: Intensity of Breathlessness
timeFrame: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
measure: Unpleasantness of Breathlessness
timeFrame: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
Secondary outcomes:
measure: Intensity of Pain
timeFrame: Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Donald A Mahler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03267823: INR Comparison Testing in Cardiac Surgery
Official title: Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Keywords: Bleeding
heart surgery
coagulation
coagulopathy
INR
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery

Brief summary: The investigator is testing blood samples to compare the results of two different techniques. Since blood loss and the need for blood transfusions continue to be major problems after heart surgery and other types of surgery, the blood clotting levels are constantly checked during heart surgery as part of clinical care.The purpose of this study is to compare the INR levels in blood before and after the heart bypass during surgery.


Eligibility criteria: Inclusion Criteria:

* Patients greater than or equal to 18 years of age.
* Patients undergoing elective surgery.
* Patients undergoing cardiac surgery.
* Patients to undergo general anesthesia with endotracheal intubation.
* Patients with well-controlled health disorders.

Exclusion Criteria:

* Patients currently on Coumadin or other anticoagulants; including, direct thrombin inhibitors and direct Xa inhibitors.
* Patients who are under 18 years of age or pregnant.
* Patients undergoing emergency surgery.
* Patients with known coagulation disorders.
* Patients who are unable to provide informed consent in the form of a signature

Primary outcomes:
measure: Change in correlation between laboratory and point of care INR
timeFrame: Baseline, Within ten minutes of completion of bypass
Secondary outcomes:
measure: Change in agreement between laboratory and point of care INR
timeFrame: Baseline, Within ten minutes of completion of bypass
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Michael Fabbro, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fabbro M 2nd, Abalo M, Fermin L, Andrews DM, Patel PA. Comparison of international normalized ratio determined by point-of-care to standard laboratory testing before and after reversal of heparin in cardiac surgery. Blood Coagul Fibrinolysis. 2020 Mar;31(2):140-144. doi: 10.1097/MBC.0000000000000889.
Clinical trial NCT05217823: Er:YAG Laser Treatment of Moderate Chronic Periodontitis
Official title: Long-term Stability of Er:YAG Laser Non-surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis, Generalized, Moderate
Keywords: Lasers
Periodontitis
Root planing
Treatment outcome
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Er:YAG laser possesses specific characteristics allowing to be used in non-surgical periodontal treatment. The aim of the resent study was to evaluate the long-term clinical effectiveness of Er:YAG laser monotherapy in the treatment of moderate chronic periodontitis and to compare it with conventional hand instrumentation.

MATERIALS AND METHODS: 451 teeth (1,099 periodontal pockets) from 30 patients with moderate chronic periodontitis (initial probing pocket depth 4 to 6 mm) were allocated for subgingival scaling and root planing in two groups - hand instrumentation (control) and Er:YAG laser instrumentation with 100mJ/15Hz (test). Using a computerized periodontal probe, patients were examined for probing pocket depth (PPD), gingival recession (GR), clinical attachment level (CAL), bleeding on probing (BOP), plaque presence (FMPS) at baseline, one, three, six and 12 months after instrumentation.


Eligibility criteria: Inclusion Criteria:

* at least two teeth per quadrant with PPD between 3,6 mm and 6,4 mm;
* loss of clinical attachment up to 4 mm
* bleeding on probing

Exclusion Criteria:

* periodontal treatment in the last 12 months;
* systemic diseases;
* systemic medication

Primary outcomes:
measure: Probing pocket depth
timeFrame: 1 year
Secondary outcomes:
measure: Gingival recession
timeFrame: 1 year
measure: Clinical attachment level
timeFrame: 1 year
measure: Bleeding on probing
timeFrame: 1 year
measure: Plaque level
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: