louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01103934: Vitamin D Plus Fluticasone Propionate
Official title: The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.


Eligibility criteria: Inclusion Criteria

1. Males and females between 18 and 45 years of age.
2. History of tree, grass and/or ragweed allergic rhinitis.
3. Positive skin test to tree, grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.

Primary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600534: GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
Official title: GooDMomS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Pregnancy
Keywords: gestational diabetes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).

Detailed description: This is a pilot trial in which 30 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2) self-directed educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with gestational diabetes
* Planning to delivery with the study area

Exclusion Criteria:

* Pre-existing diabetes (type 1 or type 2 diabetes)
* Non-English speaking
* Not planning to delivery in the study area

Primary outcomes:
measure: Change in glycosylated hemoglobin
timeFrame: Baseline and 36 weeks gestation
Secondary outcomes:
measure: Change in weight after pregnancy
timeFrame: 6 weeks postpartum to 24 weeks postpartum
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina clinics
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Wanda Nicholson, MD MPH MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.
citation: Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.
Clinical trial NCT06524934: Virtual Reality's Role in See&Treat Hysteroscopy
Official title: The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Endometrial Diseases
Myoma;Uterus
Endometrial Hyperplasia
Keywords: Outpatient Hysteroscopy
Virtual Reality Technology
Pain and Anxiety Management
See & Treat
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

-

Primary outcomes:
measure: Pain pre procedure
timeFrame: 1 minute before the procedure
measure: Anxiety pre procedure
timeFrame: 1 minute before the procedure
measure: Pain post procedure
timeFrame: 1 minute after the procedure
measure: Anxiety post procedure
timeFrame: 1 minute after the procedure
measure: Heart rate (HR) pre procedure
timeFrame: 1 minute before the procedure
measure: Respiratory rate (RR) pre procedure
timeFrame: 1 minute before the procedure
measure: Heart rate (HR) during procedure
timeFrame: 5 minutes after the start of the procedure
measure: Respiratory rate (RR) during procedure
timeFrame: 5 minutes after the start of the procedure
Secondary outcomes:
measure: Suspension rate of procedure
timeFrame: During procedure
measure: Time of procedure
timeFrame: During procedure
measure: Satisfaction rate
timeFrame: 5 minutes after the procedure
measure: Side effects
timeFrame: 5 minutes after the procedure
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: University Federico II of Naples - Italy
name: Brunella Ms Zizolfi, AssProfessor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03872934: Effect of Different Music Types on Implant Surgery Anxiety
Official title: Effect of Different Music Types on Implant Surgery Anxiety - Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety, Dental
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eighty patients aged 40-70 years will undergo elective implant surgery.

Brief summary: A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed.

This delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.


Eligibility criteria: Inclusion Criteria:

* Will undergo elective implant surgery,
* between 40-70 years

Exclusion Criteria:

* Who does not agree to participate in the study,
* Under 40, over 70 years,
* Patients with ear disorders (ie, not suitable for musical intervention),
* arrhythmia
* patients with physical condition III or higher (American Society of Anesthesiologists)

Primary outcomes:
measure: Corah's dental anxiety scale
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erzincan University
name: ilke kupeli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miyata K, Odanaka H, Nitta Y, Shimoji S, Kanehira T, Kawanami M, Fujisawa T. Music before Dental Surgery Suppresses Sympathetic Activity Derived from Preoperative Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Jul;1(2):153-162. doi: 10.1177/2380084416650613.
citation: Bodner E, Iancu I. Recalling the threat: dental anxiety in patients waiting for dental surgery. Isr J Psychiatry Relat Sci. 2013;50(1):61-6.
citation: Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.
citation: Wright H. The Correlation of Classical, Jazz, and Pop Music to a Reduction of Dental Anxiety Experienced by Adult Patients. 2018.
Clinical trial NCT06526234: Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection
Official title: Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with MR enterography examination for follow-up or suspected Crohn's disease

Brief summary: Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation.

The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients.

In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization.

In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.


Eligibility criteria: Inclusion Criteria:

Patient with MR enterography examination for follow-up or suspected Crohn's disease

No Exclusion Criteria.

Primary outcomes:
measure: Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.
timeFrame: Baseline (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
state: CHRU De Nancy
Study officials:
References:
Clinical trial NCT05452434: Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
Official title: Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the efficacy, safety and tolerability of Mirabegron and behavioral combination versus Mirabegron alone in the treatment of women with overactive bladder (OAB）.


Eligibility criteria: Inclusion Criteria:

* 1. Female aged between 40-60 years old, and no abnormalities were found in general examination, neurological examination and pelvic examination. 2. Patients with urgent urination for more than 3 months, with or without urgent incontinence, often with frequent micturition and nocturia, have normal urine routine. 3. The patients who were diagnosed as OAB by the following questionnaires, with 6≤ score ≤11 is moderate OAB, with score≥12 is severe OAB, and selected moderate and severe OAB patients. 4. Willing to join the study with signed ICF.

Exclusion Criteria:

* 1. Other diseases as obvious reasons causing OAB symptoms. 2. Patients with hypertension, of whom blood pressure is as high as 180/110 mm Hg or above. 3. Patients with gynecological malignancies, pelvic radiation therapy, stress urinary incontinence or mixed urinary incontinence with predominant stress incontinence. 4. Those taking OAB treatment drugs; 5. Pregnant (blood G-HCG determination if necessary) or lactating women; 6. Women with liver and kidney dysfunction, immunosuppressive agents, blood diseases, diabetes, mental illness or other serious diseases. 7. Poor compliance. 8. Allergic constitution, or allergic to the type of study drug

Primary outcomes:
measure: Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
timeFrame: From first dose of study drug up to month 9
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to month 9
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01354834: Assessment of the Effectiveness of Menopur in Intrauterine Insemination
Official title: Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring SAU
First posted: 2011-05-17
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females affected by infertility able to undergo intrauterine insemination

Brief summary: The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI
* Seminal sample suitable for artificial insemination treatment according to the criterion of each centre
* Patient prescribed therapy with Menopur in artificial insemination

Exclusion Criteria:

* Contraindications to intrauterine insemination
* Contraindications to Menopur

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 30 days
Secondary outcomes:
measure: Live birth rate
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Investigational site
state: Alicante
city: Las Palmas
country: Spain
facility: Investigational site
state: Grand Canaria
city: Santiago
country: Spain
facility: Investigational site
state: La Coruña
city: Reus
country: Spain
facility: Investigational site
state: Tarragona
city: Albacete
country: Spain
facility: Investigational site
city: Alicante
country: Spain
facility: Investigational site
city: Almería
country: Spain
facility: Investigational site
city: Barcelona
country: Spain
facility: Investigational site
city: Burgos
country: Spain
facility: Investigational site
city: León
country: Spain
facility: Investigational site
city: Madrid
country: Spain
facility: Investigational site
city: Sevilla
country: Spain
facility: Investigational site
city: Toldeo
country: Spain
facility: Investigational site
city: Valladolid
country: Spain
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT04914234: Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
Official title: Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypotension Drug-Induced
Keywords: atenolol
controlled hypotension
metoprolol
nasal surgery
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries.

Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding.

Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 50 years

Exclusion Criteria:

* ASA physical status \> II
* Age \< 21 years or \> 50 years
* Pregnant women
* Breastfeeding
* Bronchial asthma
* Chronic obstructive pulmonary disease
* Diabetes Mellitus
* Hypertension
* Ischemic heart disease
* Rheumatic heart disease
* Heart failure
* Heart block
* Sick sinus syndrome
* Sinus bradycardia
* Chronic hypotension
* Anemia (Hb \< 10 g/dl)
* Renal or hepatic dysfunction
* Central nervous system disease
* Allergic fungal sinusitis
* Patients on beta-blockers
* Alcohol or drug abuse
* Anticoagulation therapy,
* Bleeding diathesis
* Agents influencing autonomic nervous system
* Allergy to the study drugs
* Any contraindication of oral intake

Primary outcomes:
measure: Mean and Standard deviation of Blood loss (ml)(mean±SD)
timeFrame: 5 minutes after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00433134: Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients
Official title: Survey Investigation of Adherence to Immunosuppression and Other Medications Among Kidney Transplant Recipients at SUNY Downstate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Treatment Refusal
Patient Compliance
Keywords: renal transplant recipient
adherence
compliance
immunosuppression
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2007-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE

Brief summary: Goal:

To define the causes and issues associated with nonadherence in our population

Hypothesis:

There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients

Methods:

1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence.
2. A brief review of demographics and pertinent laboratory information at the same encounter

Detailed description: Objectives:

1. To determine the prevalence of nonadherence in our population
2. To assess possible causes of nonadherence and correlate those causes with demographic information and clinical findings
3. To assess for differences between adherence with immunosuppressive regime versus adherence with other medications (for hypertension, diabetes, hypercholesterolemia)

Methods:

1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence
2. A brief review of demographics and pertinent laboratory information at the same encounter

Eligibility criteria: Inclusion Criteria:

* All renal transplant recipients with a working transplant who are currently attending the transplant clinic and who have been transplanted 6 months to 4.5 years ago are eligible. Patients are recruited at random from the transplant clinic waiting area

Exclusion Criteria:

* Less than 6 months post-transplant
* More than 4.5 years post transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Mariana Markell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York - Downstate Medical Center
name: Sima Terebelo, MPH, RPA-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05902234: Emotional Bodymaps in Pediatric Pain Patients and Their Parents.
Official title: Emotional Bodymaps in Pediatric Pain Patients and Their Parents.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 600
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric pain clinic patients and their parents

Brief summary: The aims of this study are to find out how pain may alter the experience of emotions in the body in pediatric pain patients and how how their parent feel the emotions in their bodies. We are also interested how this possible effect is mediated by the duration and location of pain, mood changes or with the experience of bullying.


Eligibility criteria: Inclusion Criteria:

* fluency in finnish language

Exclusion Criteria:

* none

Primary outcomes:
measure: emotional bodymaps
timeFrame: 10months
Secondary outcomes:
measure: pain PROMIS
timeFrame: 10 months
measure: psychological flexibility
timeFrame: 10 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: New Childrens Hospital
Study officials:
affiliation: HUS, HY
name: Reetta M Sipilä, PhD
role: PRINCIPAL_INVESTIGATOR
References: