louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01421641: Tenaculum Pain Control Study
Official title: The Effect of Intracervical Lidocaine Injection Versus Topical Lidocaine Gel on the Pain Experienced by Patients Undergoing Tenaculum Application to the Cervix at the Time of an Office Gynecologic Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Pain
Pelvic Pain
Keywords: Tenaculum
Pain
Lidocaine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used.

The researchers hypothesize that:

1. There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
2. Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.

Detailed description: Subjects who have already scheduled an IUD insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. Only healthy women ages 18 and over with an indication for endometrial biopsy or IUD placement will be recruited. The participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. They will be asked to indicate their level of pain and level of satisfaction using a Visual Analog Scale. The primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups.

Eligibility criteria: Inclusion Criteria:

* Generally healthy women
* Age 18 and over
* Indication for endometrial biopsy or IUD placement

Exclusion Criteria:

* Allergy to lidocaine or other local anesthetic
* Pregnancy, known or suspected
* Patients who are premedicated with misoprostol
* Patients with a chronic pain condition for which the patient takes daily pain medication

Primary outcomes:
measure: Tenaculum Pain
timeFrame: After tenaculum placement
Secondary outcomes:
measure: Intervention Pain
timeFrame: after application of randomized intervention
measure: Tenaculum Placement Satisfaction
timeFrame: After placement of the tenaculum
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Paula Bednarek, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06754241: Impact of Personalized Rehabilitation Guidance
Official title: Impact of Personalized Rehabilitation Guidance Based on WeChat Official Accounts Platform on Functional Recovery and Quality of Life of Patients with Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Fuyang Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the impact of personalized rehabilitation guidance based on the WeChat Official Accounts Platform on the functional recovery and quality of life of patients with knee osteoarthritis (KOA).Ninety patients diagnosed with KOA undergoing joint replacement were included via convenient sampling.The patients were randomly divided into an observation group and a control group,with 45 patients in each group.The control group received traditional rehabilitation guidance,while the observation group received personalized rehabilitation guidance through the WeChat Official Accounts Platform in addition to the traditional guidance.Different care plans had varying effects on patients' scores on the 36-item Short Form Health Survey (SF-36),Visual Analog Scale (VAS),and Lysholm Knee Scoring Scale.


Eligibility criteria: Inclusion Criteria:

* aged 50 to 80 years;
* conscious, without cognitive impairments, and able to complete reading independently or with assistance;
* able to operate a smartphone and use WeChat;
* willing to participate in this study and provide signed informed consent.

Exclusion Criteria:

* acute cerebrovascular disease with sequelae in the past 6 months;
* coexisting primary psychiatric disorders;
* unable to perform physical exercise due to physical disability in the lower limbs;
* postoperative complications, such as deep vein thrombosis or infection;
* participation in other interventional studies.

Primary outcomes:
measure: The 36-item Short Form Health Survey (SF-36)
timeFrame: at 1 week and 1 month post-discharge
measure: Visual Analog Scale (VAS)
timeFrame: at 1 week and 1 month post-discharge
measure: Lysholm Knee Scoring Scale
timeFrame: at 1 week and 1 month post-discharge
measure: The Newcastle Satisfaction with Nursing Scale (NSNS)
timeFrame: at 1 week and 1 month post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Fuyang City
country: China
facility: Fuyang Hospital of Anhui Medical University
state: Anhui
Study officials:
References:
Clinical trial NCT03133741: Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist
Official title: Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Keywords: GIP
GIP receptor antagonist
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2017-04-28
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.

Detailed description: Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.

Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin\[9-39\], C) GIP-A + Exendin\[9-39\], or D) saline (placebo).

Eligibility criteria: Inclusion Criteria:

* Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2

Primary outcomes:
measure: Insulin levels
timeFrame: 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Center for Diabetes Research
state: Copenhagen
Study officials:
affiliation: UHGentofte, Center for Diabetes Research
name: Filip K Knop, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Helsted MM, Gasbjerg LS, Lanng AR, Bergmann NC, Stensen S, Hartmann B, Christensen MB, Holst JJ, Vilsboll T, Rosenkilde MM, Knop FK. The role of endogenous GIP and GLP-1 in postprandial bone homeostasis. Bone. 2020 Nov;140:115553. doi: 10.1016/j.bone.2020.115553. Epub 2020 Jul 27.
citation: Gasbjerg LS, Helsted MM, Hartmann B, Jensen MH, Gabe MBN, Sparre-Ulrich AH, Veedfald S, Stensen S, Lanng AR, Bergmann NC, Christensen MB, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. Separate and Combined Glucometabolic Effects of Endogenous Glucose-Dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1 in Healthy Individuals. Diabetes. 2019 May;68(5):906-917. doi: 10.2337/db18-1123. Epub 2019 Jan 9.
Clinical trial NCT03081741: Circulating Tumor DNA in Surgical Lung Cancer Patients
Official title: A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Lead sponsor: Shenzhen Gene Health Bio Tech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen People's Hospital
name: Shenzhen Second People's Hospital
name: Peking University Shenzhen Hospital
First posted: 2017-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical lung cancer patients.

Brief summary: Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.

Detailed description: Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.

The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Eligibility criteria: Inclusion Criteria:

Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent

Exclusion Criteria:

Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples

Primary outcomes:
measure: Effect of surgery on ctDNA of lung cancer patients
timeFrame: before surgery and 7days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Geng Tian, MD
role: STUDY_CHAIR
References:
citation: Peng M, Xie Y, Li X, Qian Y, Tu X, Yao X, Cheng F, Xu F, Kong D, He B, Liu C, Cao F, Yang H, Yu F, Xu C, Tian G. Resectable lung lesions malignancy assessment and cancer detection by ultra-deep sequencing of targeted gene mutations in plasma cell-free DNA. J Med Genet. 2019 Oct;56(10):647-653. doi: 10.1136/jmedgenet-2018-105825. Epub 2019 Apr 13.
Clinical trial NCT01987141: Gestational Weight Gain and the Electronic Medical Record
Official title: WATE Study - Gestational Weight Gain and the Electronic Medical Record
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Weight Gain
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations.

In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain.

The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.


Eligibility criteria: Inclusion Criteria:

* Pregnant with a single intrauterine gestation
* Present for new OB visit up to 13 weeks and 6 days gestation

Exclusion Criteria:

* They have a multiple gestation pregnancy
* They are under the age of 18
* They do not speak English

Primary outcomes:
measure: Weight gain
timeFrame: At delivery, average of 40 weeks from enrollment
Secondary outcomes:
measure: Patient perception
timeFrame: At end of pregnancy, average of 40 weeks from enrollment
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT05741541: How Would the Creation of a Follow-up Methodology in Consultation Improve the Care of the Epileptic Patient?
Official title: How Would the Creation of a Follow-up Methodology in Consultation Improve the Care of the Epileptic Patient?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Epileptics patients over 18 prsenting eligiblity criteria and and whose diagnosis has been made for less than 6 months and coming from for consultation in the Hôpital Nord Franche-Comté

Brief summary: The goal of this observationnal study is to identify the informative and educational needs of epilepsy patients to avoid interrupting the therapeutic pathway.

The main question it aims to answer are :

* Identify the patient's expectations of a nurse specializing in epilepsy in the areas of information, predictive elements of good care and adaptation to their state of health
* Identify under-addressed or misunderstood themes
* Identify patient resources and interventions already in place
* Ensuring better continuity of care
* Improve the knowledge of patients and their relatives about the management of their pathology

After a consultation with the neurologist (as part of their usual follow-up), the participants will be referred to a nurse for a semi-directive, individual interview, lasting 30 minutes and composed of open and closed questions. The announcement of the diagnosis, the quality of life or the factors contributing to the difficulties and their repercussions on a daily basis will be discussed during the interview.


Eligibility criteria: Inclusion Criteria:

* Adult epileptic patients, over 18 years old
* Patients with focal or generalized epilepsy
* Patients affiliated or entitled to a social security scheme
* Patients who have received informed information about the study and who have co- signed, with the investigator, a non-objection to participation in the study
* Patients whose diagnosis has been made for at least 6 months

Exclusion Criteria:

* Patients with intellectual disabilities
* Minors
* Untreated patients, in remission
* Patients without affiliation to a social security scheme
* Patients under guardianship or curatorship

Primary outcomes:
measure: Identify the informative and educational needs of epileptic patients to avoid disrupting the therapeutic course by an interview with an nurse.
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT04881396: Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
Official title: Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccines
Hemodialysis Complication
Keywords: immunogenicity
haemodialysis patients
SARS-Cov2 vaccine
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by chronic haemodialysis, with initiation of a vaccination by BTN162b2 mRNA Cov-19 with classical scheme

Brief summary: Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.

The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Medical prescription of BTN162b2 mRNA Cov-19 vaccine
* Treatment by chronic (\>1 month) haemodialysis

Exclusion Criteria:

* Non-recommended vaccination scheme
* Refusal to consent

Primary outcomes:
measure: Seroconversion rate after vaccination with BTN162b2 mRNA cov-19 vaccine
timeFrame: The seroconversion rate is evaluated at Day 7-Day 14 after the second dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Nephrology, Hopital Edouard Herriot
city: Pierre Bénite
country: France
facility: Department of Nephrology, Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT01068496: Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
Official title: Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pterygium
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: Singapore Eye Research Institute
First posted: 2010-02-15
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pterygium patients from the investigator's clinic as well as other clinics at the Singapore National Eye Center will be recruited for this study.

Brief summary: This study looks at global gene expression in pterygium and found the derangement of matrix genes in particular to be a feature of pterygium. In the investigators opinion, it would be more beneficial to elicit changes in gene expression before the recurrence of pterygium and by developing a panel of biomarkers that are associated with pterygium recurrence; one would be able to predict the post surgical prognosis of patients after resection.Biomarker levels will be compared to discover a biomarker panel for prediction of recurrence.

Detailed description: A comprehensive questionnaire will be used to evaluate the environmental, biological, physical and behavioral risk factors of associated with the recurrence after pterygium excision.

Slit lamp digital color photographs will be taken on primary and recurrent pterygium and pterygium will be graded in three levels of severity, based on relative transparency of pterygium tissue; grade 1 (transparent), grade 2 (intermediate), and grade 3 (opaque) to see whether the risk factors correlate to the morphology of the pterygium.

Tear samples will be collected before surgery using schirmers strip.Proteins in tear samples will be analyzed using the iTRAQ method.

The transcriptional differences in pterygium and conjunctival tissue samples will be analyzed using western blot, qPCR and immunohistochemistry assays.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary and recurrence pterygium
* Must agree to participate in this study
* Must sign informed consent form

Exclusion Criteria:

* Hepatitis
* HIV/AIDS

Primary outcomes:
measure: biomarkers
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
city: Singapore
country: Singapore
facility: Singapore National Eye Center
Study officials:
affiliation: Singapore National Eye Centre
name: Samanthila Waduthantri
role: STUDY_CHAIR
affiliation: Singapore National Eye Centre
name: Laurence Lim, MBBS
role: STUDY_CHAIR
affiliation: Singapore National Eye Centre
name: Federico Luengo Gimeno
role: STUDY_CHAIR
affiliation: Singapore National Eye Centre
name: Jodhbir Mehta
role: STUDY_CHAIR
References:
Clinical trial NCT01427296: Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Official title: A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cleansing
Keywords: Colon Cleansing
Bowel Prep
Colonoscopy
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 2154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 70 years of age, inclusive
* Scheduled for colonoscopy within 21 days of the screening visit
* Able to swallow tablets the size of a multivitamin without difficulty

Exclusion Criteria:

* History of biopsy-proven acute phosphate nephropathy
* Known allergy or hypersensitivity to treatment arms
* History of gastric stapling or bypass procedure or history of gastric retention
* History of any other sodium phosphate preparation within 6 months prior to colonoscopy

Primary outcomes:
measure: Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Carlos
country: United States
state: California
city: Bristol
country: United States
state: Connecticut
city: Macon
country: United States
state: Georgia
city: Suwanee
country: United States
state: Georgia
city: Hagerstown
country: United States
state: Maryland
city: Wyoming
country: United States
state: Michigan
city: Mexico
country: United States
state: Missouri
city: Vineland
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Plano
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
Study officials:
References: