louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01708330: The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nonviable Pregnancy
Keywords: manual vacuum aspiration
missed abortion
incomplete abortion
nonviable pregnancy
topical lidocaine
Lead sponsor: Bridgeport Hospital
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2012-10-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.

Women being treated at the Women \& Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.

The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.


Eligibility criteria: Inclusion Criteria:

* Patient at the Women and Infants Triage/Women's Emergency Department
* Vital signs are stable
* Ages 18 and older
* Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
* Estimated gestational age up to 10 weeks
* Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
* Able to read English or Spanish
* Able to give informed consent for involvement in the study

Exclusion Criteria:

* Allergic to lidocaine, iodine or betadine
* Known sensitivity to any component of the lidocaine or placebo gel.
* In acute distress
* Unable to give informed consent
* Unable to read English or Spanish

Primary outcomes:
measure: Pain during intracervical block
timeFrame: immediate
Secondary outcomes:
measure: Pain during tenaculum placement
timeFrame: immediate
measure: Pain during cervical dilation
timeFrame: immediate
measure: Pain during uterine aspiration
timeFrame: immediate
Other outcomes:
measure: Complications
timeFrame: 1 hour after procedure
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital Triage
state: Rhode Island
Study officials:
References:
Clinical trial NCT00304330: Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients
Official title: Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients; a Comparative Study With a Non-transplant Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram Negative Infection
Keywords: gram negative infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-03-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: gram negative organisms

Brief summary: The information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population. Data is needed regarding the date of admission, date of bloodstream infection and location of ward/ICU so trends in the emergence of resistance and antibiotic usage can be detected.

Detailed description: We need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. We also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history

Eligibility criteria: Inclusion Criteria:

* All patients with a positive blood culture isolate growing a gram-negative organism will be included from 1996 - 2005

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David L Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05657730: Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults
Official title: Analysis of the Intestinal Flora Composition After Consumption of Water Kefir
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Diet
Gastrointestinal Microbiome
Probiotics
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this intervention study is to analyse the microbiota composition after the water kefir consumption. The main questions are to evaluate the potential probiotic drink can have beneficial effect on the gut microbiota. Participants will consume the water kefir for two weeks and microbiota will be analysed. Researchers will compare the microbiota composition before and after consumption.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age.
* must be able to complete the form digitally.

Exclusion Criteria:

* must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency such as MS, type 1 diabetes, cancer or HIV.
* must not take antibiotics during the study period.

Primary outcomes:
measure: 16S metagenomics based measurement of the bacterial diversity (alpha- and beta diversity indices), and the composition (relative abundance of the bacterial taxa in each sample)
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
state: Skåne
Study officials:
References:
Clinical trial NCT04616430: Topical Endoxifen in Women
Official title: Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mammographic Breast Density
Lead sponsor: Atossa Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
First posted: 2020-11-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.


Eligibility criteria: Inclusion Criteria:

* Participant in the Karma Cohort
* Attending the national mammography screening program, i.e., aged 40-74 and have performed a screening mammogram maximum 3 months prior to study inclusion
* Mammographic density \~4.5 % density (volumetric) measured by Volpara, at the screening mammogram performed in connection to baseline (maximum 3 months prior to inclusion). The threshold value of 4.5% corresponds to the clinical Bl-RADS score A
* Postmenopausal, defined as no period of menstruation during last 12 months independent of any hormonal treatment
* Informed consent must be signed before any study specific assessments are performed

Exclusion Criteria:

* Any previous or current diagnosis of breast cancer (including carcinoma in situ).
* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix.
* A history of major surgery of the breast, e.g., reduction or enlargement, which might affect density measurements.
* Mammographic Bl-RADS malignancy code 3, or above, at baseline mammography, or at mammography during time of treatment. Recall for additional examinations due to technical problems with the mammogram is accepted.
* Currently using estrogen and progesterone based hormone replacement therapy (oral or patches). Local estrogen treatment is accepted (ex. Vagifem).
* Non-medical approved drugs against hot-flashes including phytoestrogen.

Primary outcomes:
measure: Change in Mammographic Breast Density At Study Exit
timeFrame: From baseline to study exit up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Sodersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Per Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Backlund M, Eriksson M, Gabrielson M, Hammarstrom M, Quay S, Bergqvist J, Hellgren R, Czene K, Hall P. Topical Endoxifen for Mammographic Density Reduction-A Randomized Controlled Trial. Oncologist. 2022 Jul 5;27(7):e597-e600. doi: 10.1093/oncolo/oyac102.
Clinical trial NCT00435630: Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery
Official title: Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Keywords: Education
Virtual Reality
Laparoscopic Surgery
Learning Curve
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-02-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students.

Detailed description: Developing objective methodology for assessing technical skill is paramount to superior surgical training. Alternatives to the traditional apprenticeship model of surgical training are necessary in today's emphasis on cost containment and professional competency.

Metrics are widely employed in virtual environments and provide a yardstick for performance measurement. The current method of defining metrics for medical simulation remains more an art than a science. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment will improve their mastery of those skills when tested in that same environment. Fewer studies have been able to document the learning curve for mastery of tasks in a virtual reality simulator. This study will investigate the learning curve for tasks in a virtual reality laparoscopic simulator.

Eligibility criteria: Inclusion Criteria:

* Medical students, years 1 through 4 are eligible.
* No prior clinical experience with laparoscopic surgery as the assistant surgeon.
* No prior simulation training (mechanical, PC-based or otherwise).

Exclusion Criteria:

* Persons who are not medical students.
* Medical students with prior clinical experience with laparoscopic surgery as the assistant surgeon.
* Medical students with prior simulation training (mechanical, PC-based or otherwise).

Primary outcomes:
measure: Establish learning curve for each of seven tasks on the simulator.
timeFrame: 6 months
Secondary outcomes:
measure: Establish test-retest reliability for each of seven tasks on the simulator.
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Dennis L Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278030: Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
Official title: Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.


Eligibility criteria: Inclusion Criteria:

* Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e. PROMOTE® or newer devices with similar functionality)
* Patients will have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D
* Patients will receive a new implant or an upgrade from an existing pacemaker or Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement
* Patients must be in sinus rhythm at the time of enrollment visit and baseline measurements

Exclusion Criteria:

* Persistent or permanent atrial fibrillation
* Heart transplantation
* Recent myocardial infarction (\< 90 days)
* Contra-indication to contrast agent
* Are less than 18 years of age
* Are pregnant
* Are currently participating in a clinical investigation that includes an active treatment arm
* Have a life expectancy of less than 6 months

Primary outcomes:
measure: Responder Rate
timeFrame: At 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: The Heart Group
state: Tennessee
Study officials:
References:
Clinical trial NCT02982330: Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes
Official title: Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is known to reduce post-meal glucose excursions but it is unknown whether lowering the carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout the day. The aim of this study is to examine, under free living conditions and using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current diabetes guidelines).


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed Type 2 Diabetes (\>6 months)

Exclusion Criteria:

* Exogenous Insulin
* A1c \> 9%
* Cardiovascular, liver, or renal other disease
* Breakfast and meal skippers

Primary outcomes:
measure: Incremental area under the glucose curve (continuous glucose monitor)
timeFrame: 24 hour (one day)
Secondary outcomes:
measure: Mean Blod Glucose (continuous glucose monitor)
timeFrame: 24 hours (one day)
Other outcomes:
measure: Glycemic Variability (continuous glucose monitor)
timeFrame: 24 hours (one day)
measure: Satiety VAS 100
timeFrame: Before and after meals (one day)
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
affiliation: UBC Okanagan
name: Jonathan P Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang CR, Francois ME, Little JP. Restricting carbohydrates at breakfast is sufficient to reduce 24-hour exposure to postprandial hyperglycemia and improve glycemic variability. Am J Clin Nutr. 2019 May 1;109(5):1302-1309. doi: 10.1093/ajcn/nqy261.
Clinical trial NCT01653925: Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression
Official title: Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Low Grade Prostate Cancer
Keywords: Prostatic Neoplasms
Low grade prostate cancer
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Canada
First posted: 2012-07-31
Enrollment: 120
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether marine omega-3 fatty acids and 5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk prostate cancer patients.

Detailed description: The study has a duration of 1 year for each participant. Subjects will be first assigned to a dietary or a dutasteride intervention that they will consume for the first 6 months. After 6 months, all men will have a combined intervention of dutasteride and diet to complete follow-up of 12 months. This will allow us to study interactive effects.

Dietary intervention consists on a high w-3 long-chain fatty acids diet without supplement and to reduce intake of saturated and trans fatty acids.

Prostatic biopsies will be taken at time of diagnosis and at 6 and 12 months after the beginning of the study. Blood will be drawn before each prostate biopsy session and urine will be collected before each prostate biopsy and after digital rectal examination.

Eligibility criteria: Inclusion Criteria:

* Low-risk prostatic neoplasms
* Candidate for active surveillance
* Informed consent

Exclusion Criteria:

* Current fish oil supplementation
* Current NSAID use

Primary outcomes:
measure: Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment
timeFrame: 0-6-12 months
Secondary outcomes:
measure: Effect of Interventions on Gene Expression Profile
timeFrame: 0-6-12 months
measure: Effects of Interventions on Hormonal Metabolism
timeFrame: 0-6-12 months
measure: Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression
timeFrame: 0-6-12 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Hotel-Dieu of Quebec
city: Quebec
country: Canada
facility: Institute of nutraceuticals and functional food of Laval University
Study officials:
affiliation: Laval University
name: Vincent Fradet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05604625: Ethically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator
Official title: A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Growth Modification
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the treatment results when treating Class II division 1 malocclusion using the Van Beek-Headgear Activator combination (vBHGA) appliance versus using the Andresen activator.


Eligibility criteria: Inclusion Criteria:

* Class II division 1 indicated by ANB angle value ≥ 4º
* Class II division 1 with overjet \> 5mm.
* An age range between 8 and 13 years growing patient using cervical vertebral stage assessment (CVS).
* No previous orthodontic treatment
* No indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination

Exclusion Criteria:

* Missing teeth (excluding 3rd molars).
* Craniofacial anomalies.
* Medical condition or prescription medication that may affect growth.
* Lack of compliance whenever documented in the charts.

Primary outcomes:
measure: treating Class II division 1 malocclusion
timeFrame: at 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar University
state: القاهرة
Study officials:
References:
citation: Altenburger E, Ingervall B. The initial effects of the treatment of Class II, division 1 malocclusions with the van Beek activator compared with the effects of the Herren activator and an activator-headgear combination. Eur J Orthod. 1998 Aug;20(4):389-97. doi: 10.1093/ejo/20.4.389.
Clinical trial NCT04014725: Validation of the Utility of Myopia Intelligent Diagnostic System
Official title: Validation of the Utility of Myopia Intelligent Diagnostic System: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 50
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: DIAGNOSTIC

Brief summary: The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.


Eligibility criteria: Inclusion Criteria:

* Student aged 6-18

Exclusion Criteria:

-

Primary outcomes:
measure: The AUC of the Myopia Intelligent Diagnostic System
timeFrame: up to 3 month
Secondary outcomes:
measure: The sensitivity of the Myopia Intelligent Diagnostic System
timeFrame: up to 3 month
measure: The specificity of the Myopia Intelligent Diagnostic System
timeFrame: up to 3 month
Other outcomes:
Locations:
Study officials:
References: