louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00219921: Postoperative Analgesia After Total Hip Replacement
Official title: Postoperative Analgesia After Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Hip Replacement
Keywords: total hip replacement
pain treatment
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.

Detailed description: This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.

VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.

Eligibility criteria: Inclusion Criteria:

* Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower

Exclusion Criteria:

* Not able to speak dutch
* communication problems
* dementia
* mental retardation

Primary outcomes:
measure: VAS-score for pain at movement and at rest every three hours
measure: PCA-bolus-sum every three-hour period
measure: Morphine-IM rescue dose every three-hour period
Secondary outcomes:
measure: patient satisfaction each 24 hours
measure: iv-morphine dose needed to attain VAS-score under 40 mm
measure: PONV every three hours
measure: urine retention every three hours
measure: itching every three hours
measure: decrease in saturation every three hours
measure: quality of physical training
Other outcomes:
Locations:
Study officials:
affiliation: Rijnstate Hospital
name: Sibrand Houtman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03297021: Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
Official title: Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Nausea and Vomiting
Keywords: ambulatory surgery
post-operative nausea and vomiting
general anesthesia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Detailed description: Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.

Eligibility criteria: Inclusion Criteria:

* ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

Exclusion Criteria:

* Patients with allergies or contraindications to study medications

Primary outcomes:
measure: Nausea Scale
timeFrame: average of 4 hours in PACU and POD1
Secondary outcomes:
measure: Number of Participants With Episodes of Vomiting in the PACU
timeFrame: average of 4 hours
measure: Number of Participants With Symptoms on POD 1
timeFrame: Day 1
measure: Number of Participants Who Needed Rescue Anti-emetics
timeFrame: average of 4 hours
measure: Total Anesthesia Time
timeFrame: intraoperative, up to 3.5 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniel Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01789021: Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany
Official title: Analytical Performance Evaluation of Blood Glucose Monitoring Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: blood glucose monitoring systems
ISO 15197
system accuracy
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2013-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Male or female subjects with type 1 or type 2 diabetes or healthy subjects
* For BG adjustment people with type 1 diabetes

Exclusion Criteria:

* Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
* For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
* Legal incompetence or limited legal competence
* Age \< 18 years
* Dependency from the sponsor or the clinical investigator
* Mental incapacity or language barriers precluding adequate compliance with the study procedures

Primary outcomes:
measure: Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value
timeFrame: For each subject, the experimental phase has an expected duration of up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study officials:
References:
citation: Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161.
citation: Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Hogel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diabetes Technol Ther. 2015 Sep;17(9):625-34. doi: 10.1089/dia.2015.0043. Epub 2015 May 19.
Clinical trial NCT06290921: Ovulation Triggering 2 vs 3 Follicles
Official title: Ovulation Trigger With Less Than 3 Follicles in Stimulated In-vitro Fertilization (IVF) Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 405
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data spreadsheet from 2011 to 2017 of patients having undergone an IVF cycle

Brief summary: Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles.


Eligibility criteria: Inclusion Criteria:

* Stimulated IVF cycle at clinique ovo
* Patients with a maximum of 3 mature follicles (≥14mm) on the day of ovulation trigger

Exclusion Criteria:

* Cycle cancelation due to no follicles
* History of recurrent implantation failure
* Contraindication of ovulation induction medication

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 6 to 8 weeks after Frozen Embryo Transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Louise Lapensée, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02436421: Impact of Best Practice Alerts in Cardiology Outpatient Clinics
Official title: Impact of Best Practice Alerts in Cardiology Outpatient Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Atrial Fibrillation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation.

Detailed description: Best Practice Alerts based will be created for hypertension and atrial fibrillation. Outpatient cardiology providers will be randomly allocated into one of three groups. The first group will receive the BPA for hypertension alone. The second group will receive the BPA for atrial fibrillation alone. The final group will receive both BPAs. The rate of blood pressure control for all patients and anticoagulation in patients with atrial fibrillation in each group will be evaluated prior to and after the implementation of the BPAs to determine the effect of the BPA.

Eligibility criteria: Inclusion Criteria:

* all patients seen routinely by cardiologists at Duke

Exclusion Criteria:

* none

Primary outcomes:
measure: Rates of anticoagulation among patients with atrial fibrillation
timeFrame: 1 year
measure: Rates of hypertension control among patients seen by cardiology
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02110121: Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos
Official title: Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unwanted Tattoos
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate the Picosure and Revlite Laser Systems for the treatment of unwanted tattoos.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old.
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitizing medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloid scar formation.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.14. The subject has red tattoo ink allergy

Primary outcomes:
measure: Tattoo Clearance
timeFrame: 2 months post each patient's last treatment, approximately 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Westford
country: United States
facility: Cynosure Inc.
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT00929721: A Global Active Surveillance for Community Acquired Pneumonia
Official title: Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Acquired Pneumonia
Keywords: CAP
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 5172
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.


Eligibility criteria: Inclusion Criteria:

* Adult subjects 50 years of age or older
* Subject must reside in the surveillance area
* Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP

Exclusion Criteria:

* Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital).
* Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).

Primary outcomes:
measure: Incidence rates of CAP in adults 50 years and older
timeFrame: up to 120 days from enrollment
Secondary outcomes:
measure: Frequency of bacterial agents associated with CAP, Case fatality and incidence rates of CAP number and characteristics of subjects from outpatient clinics, emergency rooms, and hospital in-patient departments
timeFrame: up to 120 days from enrollment
Other outcomes:
Locations:
city: Chrzanow
country: Poland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00908921: Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Official title: Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed \<6 months and who had not taken oral antidiabetic medication or insulin for \>3months.
* HbA1C more than 7.5 and less than 11.

Exclusion Criteria:

* Fasting plasma glucose of \>13.5mmol/L
* Type 1 Diabetes Mellitus (T1DM)
* Patient with acute illness hospitalized in last 2 months
* Patient with active liver disease, impaired renal or hepatic functions
* Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
* Pregnant and lactating women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in glycosylated hemoglobin (HbA1c) rate
timeFrame: week 16
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) rate
timeFrame: week 16
measure: Post Prandial Glucose (PPG) rate
timeFrame: week 16
measure: Percentage of patients achieving HbA1c <7.0
timeFrame: week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Mei Mao
role: STUDY_DIRECTOR
References:
citation: Guo XH, Lv XF, Han P, Zhang XZ, Yang HZ, Duan WR, Gao Y. Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus. Curr Med Res Opin. 2013 Mar;29(3):169-74. doi: 10.1185/03007995.2013.765396. Epub 2013 Jan 24.
Clinical trial NCT02686021: Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
Official title: Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.


Eligibility criteria: Inclusion Criteria:

* planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia)
* able to understand the study and the NRS scale

Exclusion Criteria:

* simultaneous both sided extraction or only upper third molar extraction
* general anesthesia
* known or presumed abnormal coagulation status
* known or presumed liver or renal dysfunction
* contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against NSAIDS, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding)
* contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against Nonsteroidal anti-inflammatory drugs (NSAID), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding)
* pregnancy and breast feeding mothers

Primary outcomes:
measure: area under the curve for pain in the first 12 postoperative hours
timeFrame: first 12 postoperative hours
Secondary outcomes:
measure: area under the curve for pain in the first 18 postoperative hours
timeFrame: first 18 postoperative hours
measure: highest pain score
timeFrame: total observation period (maximum 18 hours)
measure: night time pain
timeFrame: first night after the intervention
measure: need for and timing of rescue medication
timeFrame: total observation period (maximum 18 hours)
measure: haemorrhage requiring intervention
timeFrame: total observation period (maximum 18 hours)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anesthesia, University of Basel Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Wilhelm Ruppen, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: