louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00676312: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Official title: A Partially-Blinded, Randomized, Placebo and Active Controlled, Ascending Single-Dose Crossover Phase I Study to Explore the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of PTH134 Formulated With Different Concentrations of 5-CNAC in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis
parathyroid hormone
pharmacodynamic
pharmacokinetic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.


Eligibility criteria: Inclusion Criteria:

* Healthy postmenopausal female subjects, 40 to 70 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
* Body mass index (BMI) within the range of 19 to 32.

Exclusion Criteria:

* Smokers who report cigarette use of \>= 5 cigarettes per day.
* Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening.
* Previous osteoporosis treatment
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: •Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours.
Secondary outcomes:
measure: •Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharma AG, Basel
name: Novartis Pharma AG, Basel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammerle SP, Mindeholm L, Launonen A, Kiese B, Loeffler R, Harfst E, Azria M, Arnold M, John MR. The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women. Bone. 2012 Apr;50(4):965-73. doi: 10.1016/j.bone.2012.01.009. Epub 2012 Jan 25.
Clinical trial NCT01790412: Gestational Diabetes: the Prevention
Official title: Gestational Diabetes. The Rol of Exercise in the Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy, exercise, gestational diabetes
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 257
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.

Detailed description: A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women
* At week 8-14
* Adherence 80% (minimum) until the end of pregnancy

Exclusion Criteria:

* Contraindications appointed by American College of Obstetricians \& Gynecologists (ACOG)
* No adherence

Primary outcomes:
measure: prevention gestational diabetes
timeFrame: weeks 24-30
Secondary outcomes:
measure: Maternal weight gain
timeFrame: weeks 40-42
Other outcomes:
measure: Other pregnancy outcomes
timeFrame: After delivery
Locations:
city: Madrid
country: Spain
facility: Technical University of Madrid
Study officials:
affiliation: Technical University of Madrid
name: Rubén Barakat, PhD
role: STUDY_DIRECTOR
affiliation: Technical University of Madrid
name: Yaiza Cordero, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordero Y, Mottola MF, Vargas J, Blanco M, Barakat R. Exercise Is Associated with a Reduction in Gestational Diabetes Mellitus. Med Sci Sports Exerc. 2015 Jul;47(7):1328-33. doi: 10.1249/MSS.0000000000000547.
Clinical trial NCT06409312: Digital Healthcare App After Total Hip Arthroplasty
Official title: Assessing the Feasibility of a Digital Healthcare App for Patient Rehabilitation After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Total Hip Replacement
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study examines the effectiveness of rehabilitation after hip replacement surgery using a specialised app called Akina Cloud. Medical professionals at the Schulthess Clinic will provide detailed information about the study. Participants must meet certain eligibility requirements. There will be time for consideration before enrolment. A demonstration of how to use the app will be provided upon agreement. Participants will be shown how to set up their profile and interact with a real therapist who will provide feedback. The initial 30-minute introduction is scheduled to take place a few days after surgery while still in hospital. Participants will be asked to complete several questionnaires. The rehabilitation process involves using the app for at least 12 weeks, at least three times a week, for 20-30 minutes per session. Direct communication with the therapist via the app is available for any queries. Follow-up questionnaires will be emailed at 6 and 12 weeks, after training, and again at 26 weeks to assess progress and feedback on the use of the app. Each session with the app lasts about 20 minutes and the questionnaire takes about 30 minutes to complete.


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* Unilateral initial implantation of a minimally-invasive hip endoprosthesis
* Age between 18 and 75 years old
* Ownership of a private laptop or desktop computer
* Stable internet connection at home
* Familiarity with the use of laptop or desktop computer

Exclusion Criteria:

* Bilateral initial implantation of a minimally-invasive hip endoprosthesis
* Not fluent in German or English
* Other conditions where active therapy is contraindicated
* Neurological diseases that limit the ability to walk
* Chronic lower limb pain
* Rheumatological diseases
* Other inflammatory diseases

Primary outcomes:
measure: Number of completed training sessions and the number of repetitions per sessionweeks of training.
timeFrame: after 12 weeks
Secondary outcomes:
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Net Promoter Score (NPS)
timeFrame: 6 weeks, 12 weeks
measure: Post-Study System Usability Questionnaire (PSSUQ)
timeFrame: 6 weeks, 12 weeks
measure: Hip disability and Osteoarthritis Outcome Score
timeFrame: 6 weeks, 12 weeks, 26 weeks
measure: International Physical Activity Questionnaire
timeFrame: 6 weeks, 12 weeks, 26 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05316012: The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment
Official title: The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence
Keywords: incontinence
sensor technology
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts when the diaper requires changing. Potential benefits of the smart diaper compared to incontinence management products without sensor technology include: workload reduction, increased comfort for residents and staff, more person-centred care, increased quality of care, less skin damage and economic (e.g. less costs due to less excessive diaper changes), and/or environmental (e.g. less waste) gains.


Eligibility criteria: Inclusion Criteria:

* Resident of nursing home
* Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and night. (Score assessed in one week interval before start study period 1 and 2 "D1")
* Wearing adult diapers as incontinence material, size M.
* Unable to change diaper independently when saturated or leaking (Katz score toileting ≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")
* Written informed consent from resident or resident's legal representative.
* Dutch speaking

Exclusion Criteria:

* Residents who are receiving end-of-life care
* Residents with a Mini-Mental State Examination (MMSE)-score of \< 24
* Residents with a dominant belly sleeping position

Primary outcomes:
measure: Mean percentage saturation
timeFrame: 10 days
measure: The % of correct warnings
timeFrame: 10 days
measure: Frequency of skin irritations
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oudenaarde
country: Belgium
facility: WZC Heilig Hart vzw
Study officials:
References:
Clinical trial NCT03024112: Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients
Official title: Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pulmonary Complications
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length of stay.

Detailed description: The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce ICU and hospital length of stay.

Eligibility criteria: Inclusion Criteria:

* Undergoing Thoracic surgery
* Planned admission to ICU after surgery

Exclusion Criteria:

* Younger than 18
* Pregnant
* Breast feeding
* Known diagnosis of obstructive sleep apnea
* Current or previous lung transplant
* Pneumonectomy
* Home oxygen greater than 4L/minute
* Inability to adhere to assigned treatment prior to 48 hours of surgery or until transferred to a floor

Primary outcomes:
measure: Number of Participants With Post-operative Pulmonary Complications
timeFrame: 30 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: 30 days
measure: Lowest Oxygen Saturation Level Measured
timeFrame: 30 days
measure: ICU Length of Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Unversity of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason Brainard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06084312: Contact Registry for Clinical Trials
Official title: Contact Registry for Clinical Trials At the University of Central Florida College of Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: This is the Contact Registry
Keywords: Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This registry will not target any specific populations.

Brief summary: The purpose of the Contact Registry for Clinical Trials is to develop a database/listserv of persons interested in clinical trials occurring at the University of Central Florida College of Medicine.

Sign up for the UCF College of Medicine's Contact Registry for Clinical Trials to learn about clinical research and clinical trials in areas of interest to you!

https://ucf.qualtrics.com/jfe/form/SV_do4WGvKlz4f8Wwe

Detailed description: The Contact Registry for Clinical Trials allow persons to sign up to learn more about clinical trials and clinical research around certain medical indications that will be occurring at the University of Central Florida College of Medicine. Persons are not asked to provide any personal health information. Persons are asked to provide identifying information needed to provide the requested information.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Persons who do not read English could register through the assistance of their friends or software for translation

Exclusion Criteria:

* Children may not register
* Persons who are unable to consent may not register

Primary outcomes:
measure: To allow persons to sign up to learn more about clinical trials and clinical research around certain medical indications that will be occurring at the University of Central Florida College of Medicine
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT02062112: Improving Tolerability of Bowel Preparation Laxative for Colonoscopy
Official title: Comparison of Patterns of Laxative Ingestion to Improve Bowel Preparation for Colonoscopy: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Bowel Preparation
Keywords: Bowel preparation solutions
Colonoscopy
Polyethylene glycol
Lead sponsor: Howard University
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test.

Investigators hypothesize that patients will have a better experience if patients taste the bowel preparation laxative with and without flavoring and then decide how they want to drink the rest of the laxative since taste preferences vary widely from person to person.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older) referred for outpatient colonoscopy

Exclusion Criteria:

* Patients with history of bowel resection
* patients with history of inflammatory bowel disease
* History of polyposis syndrome
* History of colorectal cancer
* History of poor taste perception from any cause

Primary outcomes:
measure: Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)
timeFrame: At the time of colonoscopy
Secondary outcomes:
measure: Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale
timeFrame: At the colonoscopy
Other outcomes:
measure: Prevalence of colorectal neoplasia (polyps, adenoma and cancer)
timeFrame: At the colonoscopy
measure: Correlation of beverage intake patterns with tolerability of bowel laxatives
timeFrame: At the time of colonoscopy
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
Study officials:
affiliation: Howard University
name: Adeyinka O Laiyemo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes A, Buffum M, Fuller D. Bowel preparation comparison: flavored versus unflavored colyte. Gastroenterol Nurs. 2003 May-Jun;26(3):106-9. doi: 10.1097/00001610-200305000-00004.
Clinical trial NCT01136512: Metformin Use and Vitamin B12 Deficiency
Official title: Metformin Use and Vitamin B12 Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin B12 Deficiency
Type 2 Diabetes Mellitus
Keywords: metformin
vitamin B12
type 2 diabetes
methylmalonic acid
deficiency
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient and hospitalized patients with type 2 diabetes mellitus

Brief summary: The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.


Eligibility criteria: Inclusion Criteria:Age 20-80; diagnosed with type 2 diabetes for at least 30 days

Exclusion Criteria:known vitamin B12 or folate deficiency; pernicious anemia; on vitamin B12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease

Primary outcomes:
measure: Vitamin B12 level
timeFrame: Single point
Secondary outcomes:
measure: methylmalonic acid
timeFrame: single point
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Neil Cohen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05078112: Sleep Device Testing to Promote Sleep in Infants
Official title: Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.


Eligibility criteria: Inclusion Criteria:

1. Age between 2-12 months.
2. Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.

Exclusion Criteria:

1. Diagnosed comorbid health problem that may disrupt sleep.
2. History of birth prior to 37 weeks gestational age.

Primary outcomes:
measure: Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary
timeFrame: Baseline to 5 days post-intervention
Secondary outcomes:
measure: Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score
timeFrame: Baseline to post-intervention (approximately 20 days)
measure: Change in Caregiver Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to post-intervention (approximately 20 days)
measure: Change in Patient Health Questionnaire-2 (PHQ-2) Score
timeFrame: Baseline to post-intervention (approximately 20 days)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke
name: Sujay Kansagra, MD
role: PRINCIPAL_INVESTIGATOR
References: