louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01270256: NasoNeb Delivery of an Intranasal Steroid
Official title: Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perennial Allergic Rhinitis
Keywords: allergy
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: MedInvent, LLC
First posted: 2011-01-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).


Eligibility criteria: Inclusion Criteria

1. Males and females between 18 and 55 years of age.
2. History of perennial allergic rhinitis.
3. Positive skin test to dust mite, dog, cat or indoor mold antigen.
4. And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry and total nasal symptom score greater than 8.

Exclusion Criteria

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Subjects treated with systemic steroids during the previous 30 days.
4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
7. Subjects treated with immunotherapy and are escalating their dose.
8. Subjects on chronic anti-asthma medications.
9. Subjects with polyps in the nose or a significantly displaced septum.
10. Upper respiratory infection within 14 days prior to study start.

Primary outcomes:
measure: Change in Nasal Peak Inspiratory Flow (NPIF)
timeFrame: Baseline and 26 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown K, Lane J, Silva MP, DeTineo M, Naclerio RM, Baroody FM. A pilot study of the effects of intranasal budesonide delivered by NasoNeb(R) on patients with perennial allergic rhinitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):43-8. doi: 10.1002/alr.21239.
Clinical trial NCT04212156: Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients
Official title: Validity of Thyromental Height Test (TMHT) as an Objective Predictor of Difficult Airway in Obese Patients: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Airway Intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sex, aged between 18-60 years old, ASA physical status II\& III with BMI \> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy

Brief summary: Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18-60 years old, ASA physical status II\& III with BMI \> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy

Exclusion Criteria:

* Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded

Primary outcomes:
measure: TMHT
timeFrame: before induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Abeer Ahmed
state: Cairo
Study officials:
References:
Clinical trial NCT05630456: The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome
Official title: The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Physical Activity
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In the intervention group, the researcher provided feedback on the participants' exercise amount through telephone contact every two weeks during the 12-week study period. It includes recommendations for continuing exercise therapy based on the recommendations for physical activity. Through phone consultations, they answered questions about exercise or discussed problems, were encouraged to continue exercising, answered questions or discussed problems related to wearable devices and apps, and encouraged for continuous data transmission.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Effect of Health Provider's Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study

Detailed description: Patients diagnosed with metabolic syndrome were recruited and prescribed to live for 12 weeks using a wrist-wearable device (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=35) and control group (n=32). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Eligibility criteria: Inclusion Criteria:

* smart phone user

Exclusion Criteria:

-

Primary outcomes:
measure: Fasting blood tests on baseline and 12th week visits
timeFrame: Baseline and 12week
measure: Changes in blood pressure (systolic blood pressure, diastolic blood pressure) at baseline and 12 weeks
timeFrame: Baseline and 12week
measure: Changes in waist circumference (cm) at baseline and 12 weeks
timeFrame: Baseline and 12week
measure: Measurement of physical activity through wearable devices
timeFrame: For 12 weeks
Secondary outcomes:
measure: Changes in body composition at baseline and 12 weeks
timeFrame: Baseline and 12week
Other outcomes:
measure: Gathering subject information from the survey
timeFrame: Baseline
measure: Satisfaction of using wearable-smartphone apps using visual analog scale (VAS)
timeFrame: At 12th week
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
References:
Clinical trial NCT04208256: Food Intake and the Adolescent Brain
Official title: The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents With and Without Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding Behavior
Brain
Adolescent
Keywords: pediatric obesity
resting-state functional magnetic resonance imaging
disinhibited eating behavior
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-12-23
Enrollment: 63
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with severe obesity enrolled from a specialty care lifesstyle medicine clinic and from the surrounding community. Adolescents with healthy weight enrolled from primary care clinic and from teh surrounding community.

Brief summary: The brain plays an integral role in how and what people eat. However, the brain's contribution to overeating is not well understood during sensitive developmental periods such as adolescence, when excessive weight gain and obesity prevalence are a significant concern.The proposed study will use functional magnetic resonance imaging to examine how the brain's response to excess energy is related to overeating in adolescents with and without obesity.


Eligibility criteria: Inclusion Criteria:

* male or female
* 13-18 years-old
* resident of Colorado

Exclusion Criteria:

* weigh less than 88 pounds or have a BMI% rank of \<10% for age and sex;
* have a physician's diagnosis of metabolic syndrome or diabetes (Type 1 or 2);
* have a physician's diagnosis of anorexia nervosa or bulimia nervosa;
* currently taking anti-psychotic medications (not including anti-depressant or anti- anxiety medications);
* have a non-MRI safe device (e.g. pacemaker or defibrillator) or metal in the body (e.g. metal pins, shrapnel);
* experience symptoms of claustrophobia when in small or closed-off places;
* are pregnant or plan to become pregnant

Primary outcomes:
measure: Brain function
timeFrame: brain imaging visit 1 (study visit 1); 30 minutes
measure: Disinhibited eating behavior
timeFrame: study visit 2; 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT05085756: Transdiagnostic Internet Intervention to Improve Mental Health Among University Students
Official title: Swedish Partnership in the WHO-WMH-ICS Study on National Mapping and E-health Interventions for Mental Health Issues Among University Students: Psychological Internet Treatment for Improved Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Disorder
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Malmö University
name: Stockholm University
name: Karolinska Institutet
First posted: 2021-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey.


Eligibility criteria: Inclusion Criteria:

* PHQ-9 cutoff for mild depression
* GAD-7 cutoff for mild anxiety

Exclusion Criteria:

* Suicidal ideation or plans
* Severe levels of mental ill-health

Primary outcomes:
measure: PHQ-9 for depression
timeFrame: last 2 weeks
measure: GAD-7 for anxiety
timeFrame: last 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Dept of Psychology, Uppsala University
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson C, Bendtsen M, Lindfors P, Molander O, Lindner P, Topooco N, Engstrom K, Berman AH. Does the management of personal integrity information lead to differing participation rates and response patterns in mental health surveys with young adults? A three-armed methodological experiment. Int J Methods Psychiatr Res. 2021 Dec;30(4):e1891. doi: 10.1002/mpr.1891. Epub 2021 Aug 21.
citation: Berman AH, Topooco N, Lindfors P, Bendtsen M, Lindner P, Molander O, Kraepelien M, Sundstrom C, Talebizadeh N, Engstrom K, Vlaescu G, Andersson G, Andersson C. Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial. Trials. 2024 Mar 1;25(1):158. doi: 10.1186/s13063-024-07986-1.
Clinical trial NCT01907256: Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty
Official title: Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cosmetic Outcome
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Detailed description: Approaches to rhinoplasty can be separated into two broad categories: external and endonasal, which each of them their own proponent. However, the external approach provide better exposure, critics against this technique is often due to cosmetic deformity regarding the incision. Hence, over the recent years surgeons have modified the trans-columellar incision into two big categories: gull wing and stair steps. While each of them has its own proponents, there is no randomized trial, comparing their cosmetic results.

There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Eligibility criteria: Inclusion Criteria:

* All patients who candidate for open rhinoplasty

Exclusion Criteria:

* Revision cases
* History of scar
* Systemic diseases

Primary outcomes:
measure: Hollunder cosmetic score
timeFrame: one week after surgery,
measure: Hollunder cosmetic score
timeFrame: one month after surgery
measure: Hollunder cosmetic score
timeFrame: one year after surgery
Secondary outcomes:
measure: Visual analogue score
timeFrame: one week after surgery,
measure: Visual analogue score
timeFrame: one month after surgery
measure: Visual analogue score
timeFrame: one year after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Babak Saaedi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05899556: Pinpointing the Factors Affecting Clinical Study Experiences of Pulmonary Fibrosis Patients
Official title: A Comprehensive View of Patient Experiences of Individuals Participating in Pulmonary Fibrosis Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Fibrosis
Keywords: Pulmonary Fibrosis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary fibrosis who are actively participating in a clinical research, but have not yet completed enrollment and randomization.

Brief summary: Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what research attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of pulmonary fibrosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary fibrosis patients.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of pulmonary fibrosis
* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.

Exclusion Criteria:

* Enrolled in another research study
* Inability to provide written informed consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Primary outcomes:
measure: Number of pulmonary fibrosis patients who decide to participate in a clinical study
timeFrame: 3 months
measure: Rate of patients who remain in an pulmonary fibrosis clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Aiello M, Bertorelli G, Bocchino M, Chetta A, Fiore-Donati A, Fois A, Marinari S, Oggionni T, Polla B, Rosi E, Stanziola A, Varone F, Sanduzzi A. The earlier, the better: Impact of early diagnosis on clinical outcome in idiopathic pulmonary fibrosis. Pulm Pharmacol Ther. 2017 Jun;44:7-15. doi: 10.1016/j.pupt.2017.02.005. Epub 2017 Feb 28.
citation: Glass DS, Grossfeld D, Renna HA, Agarwala P, Spiegler P, DeLeon J, Reiss AB. Idiopathic pulmonary fibrosis: Current and future treatment. Clin Respir J. 2022 Feb;16(2):84-96. doi: 10.1111/crj.13466. Epub 2022 Jan 10.
citation: O'Riordan TG, Smith V, Raghu G. Development of novel agents for idiopathic pulmonary fibrosis: progress in target selection and clinical trial design. Chest. 2015 Oct;148(4):1083-1092. doi: 10.1378/chest.14-3218.
Clinical trial NCT06535256: Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy
Official title: Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

Detailed description: Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.

Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.

Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.

Eligibility criteria: Inclusion criteria:

* Patients scheduled for laparoscopic cholecystectomy
* Age 18-60 years
* American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria:

* Patients with diabetes mellitus
* Allergy to the study drugs
* Patients on steroids
* Pregnant females
* Patients with cardiac, pulmonary, hepatic or renal disorders

Primary outcomes:
measure: incidence and severity of postoperative pain for 24 hours
timeFrame: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Zaher
Study officials:
References:
Clinical trial NCT02324556: A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial
Official title: A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Neoplasm
Keywords: Rectal Cancer
Surgery
Laparoscopy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer possible to operate with an anterior resection.

Brief summary: All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.

Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

Detailed description: The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.

It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.

Eligibility criteria: Inclusion Criteria:

* presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
* possible to operate with laparoscopic technique
* possible to operate in regard to concomitant disease
* giving informed consent to participate

Exclusion Criteria:

-Participation in other trials in conflict with the protocol and end-points the LATA-trial

Primary outcomes:
measure: Number of specimens with grade I specimen according to Quirke
timeFrame: 4 weeks postoperatively
Secondary outcomes:
measure: Conversion rate
timeFrame: day of surgery
measure: Re-admission
timeFrame: 30 days
measure: Postoperative complications scored according to Clavien-Dindo within the first 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
city: Trollhattan
country: Sweden
facility: NU-sjukvården
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset/Östra
name: Eva Angenete, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: