louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00008762: Bone Health of People With Cystic Fibrosis
Official title: Bone Health of People With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2001-01-18
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: People with cystic fibrosis (CF) now frequently live into adulthood and with this extended life expectancy has come new clinical problems. Poor bone health, including osteoporosis and bone fractures, is one of these increasingly important conditions. Preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth (weight and height) and obtaining maximal amount of bone mass during growth and development. This study will identify factors that influence bone health in a sample of children, adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods (peripheral quantitative computerized tomography \[p-QCT\] and bone sonometer). We will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with CF.

Detailed description: A total of 100 subjects with CF and pancreatic insufficiency (8-25 y, half female) will be recruited from the Children's Hospital of Philadelphia (CHOP) and the Delaware Valley region. All subjects will have baseline measurements obtained at the Nutrition and Growth Lab at CHOP. A subset of subjects will return for 12-month follow-up measurements.

We will evaluate the influences on bone health, including: gender, stage of pubertal development, body weight and height, food intake (especially calcium and vitamin D), use of steroid medications by mouth, IV administration or inhalation, physical activity and lung health. We will also follow the changes in bone health and growth over 12 months, and see what factors are associated with good and poor bone development.

In addition, the information from this study will be very important to planning the future trials of medication and other interventions to treat and, hopefully, to prevent poor bone health in people with CF.

Eligibility criteria: Inclusion:

* Diagnosis of cystic fibrosis with pancreatic insufficiency
* FEV-1 ? 40% predicted

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02275962: Drug-Drug Interaction Study in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of K-877 in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 72 hours
Secondary outcomes:
measure: Area under concentration curve (AUC)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Stuart Campbell
role: STUDY_DIRECTOR
References:
Clinical trial NCT02607462: PRP Therapy to m. Gluteus Medius During THA
Official title: Single Injection of Platelet-rich Plasma (PRP) to m. Gluteus Medius During Total Hip Arthroplasty Using Direct Lateral (Hardinge) Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Satakunta Central Hospital
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study purpose is to evaluate perioperative usefulness of Platelet-rich Plasma (PRP) in total hip arthroplasty (THA) surgery. The study is designed as a randomized double blinded study using saline as placebo. The measurement outcomes includes objective variables (MRI, dynamometer) as well as subjective measurements (Oxford Hip Score, Harris Hip Score).

Patients are assigned to two different groups, according to a randomization list. PRP (approximately 9ml from which 1ml is delivered to in-house laboratory for the measurement of platelet count) is obtained from venous blood and applied to m. gluteus medius during the closure of modified lateral approach (Hardinge).

Study participants are evaluated preoperatively by trained physiotherapist. After surgery, participants undergo clinical evaluation and imaged (MRI) at 3 and 12 months post-operative. In the same time points, strength, Harris Hip Score and Oxford Hip Score. At the end of the study, the nature of the injected substance is revealed to the patients.


Eligibility criteria: Inclusion Criteria:

* Clinically and radiology confirmed arthritis which treatment is total hip arthroplasty.

Exclusion Criteria:

* Revision surgery, insulin dependent diabetes and other endocrinology disease, smoking, use of per os cortisone, malignancy, rheumatoid arthritis, any autoimmune disease, alcoholist, previous fracture to hip, patients with diagnosed mental illness, absolute contraindications for MRI study

Primary outcomes:
measure: The decrease of T2 weighted signaling between PRP and placebo group
timeFrame: Change from 3 months at 12 months
Secondary outcomes:
measure: Differences in Harris Hip Score points between PRP and placebo group
timeFrame: Change from 3 months at 12 months
measure: Comparison of hip abduction strengths between PRP and placebo group using dynamometer
timeFrame: Change from 3 months at 12 months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta Central Hospital
Study officials:
References:
citation: Aavikko A, Puhakka J, Haapala J, Kukkonen J, Makela K, Kosola J. Perioperative platelet rich plasma (PRP) in total hip arthroplasty through the Hardinge approach: protocol to study the effectiveness for gluteus medius healing. J Exp Orthop. 2018 Jun 19;5(1):23. doi: 10.1186/s40634-018-0127-7.
Clinical trial NCT06941662: Huntington's Disease Biobank: Advancing Remote Monitoring and Deep Phenotyping
Official title: HD Project: Neurodegenerative Disease Research Platform - Novel Remote Monitoring and Deep Phenotyping.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Huntington Disease
Keywords: Huntington's disease biomarkers
remote monitoring
biobank
observational study
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Schwab Charitable Fund
First posted: 2025-04-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community, neurology clinics, hospital, huntington's disease centers of excellence.

Brief summary: This observational study aims to identify novel biomarkers of disease onset and progression in Huntington's disease by integrating remote monitoring with fluid biomarkers. Using video-based computer vision and mobile app-based cognitive assessments combined with machine learning algorithms, we aim to develop markers that can be used by Huntington's disease patients at home.

Using machine learning to analyze videos of movement will capture the movements with an accuracy that will be as good as seeing an expert neurologist. These individualized markers can be followed over time to evaluate symptoms onset and change. The study will track disease progression and correlate these digital markers with changes in plasma and cerebrospinal fluid. The ultimate goal is to advance biomarker discovery and therapeutic development for Huntington's disease.

The study includes one in-person visit per year. A remote visit via Zoom or Facetime (15 min) every three months to record videos of movement. We can also share cutting-edge wristbands and a mobile phone app.


Eligibility criteria: Inclusion Criteria:

* Individuals with a positive test for the HD expansion mutation.

Exclusion Criteria:

* Individuals with movement disorders with a negative test for the HD expansion mutation.

Primary outcomes:
measure: Unified Huntington's Disease Rating Scale (UHDRS)
timeFrame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
measure: 30-second Chair Stand Test
timeFrame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kyan Younes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046162: A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions
Official title: An Open Label,Crossover,Randomized Study Of Two Periods,Two Treatments,Two Sequences, And A Single Dose Of Two Oral Drug Products Of Alprazolam 2mg (Tafil (r), Product Of Pharmacia& Upjohn S.a De C.v Vs Xanax 2mg, Product Of Pfizer Pharmaceuticals Llc) In Healthy Volunteers In Fasting Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Alprazolam
Tafil
Xanax
Bioequivalence
Drug Kinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
First posted: 2010-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (male or female)
* Age between 18-40 years
* body mass index (Quetelet´s index) between 18-27

Exclusion Criteria:

* Unhealthy subjects
* Volunteers who require any medication over the course of the study
* Volunteers who have received investigational drugs within 60 days prior to the study

Primary outcomes:
measure: Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam.
timeFrame: 10 days
measure: Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence.
timeFrame: 10 days
Secondary outcomes:
measure: Investigate the safety of both preparations based on the record of adverse events on completing both study periods.
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03470662: Prevention of Delirium Among Elderly Patients With Hip Fractures
Official title: Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Hip Fractures
Keywords: Hip fractures
Delirium
Aged
Care bundle
Lead sponsor: Zhoupu Hospital, Pudong New Area, Shanghai, China
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.

Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.


Eligibility criteria: Inclusion Criteria:

* ≥65 years
* with hip fractures
* treated surgically

Exclusion Criteria:

* \<65 years
* psychiatric history
* ICU post-operation
* refuse to join this study
* have delirium pre-operation

Primary outcomes:
measure: incidence of delirium among elderly patients with hip fractures
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhoupu Hospital Shanghai
Study officials:
References:
Clinical trial NCT06994962: Multi-Component Breath Alcohol Intervention Phase 3
Official title: Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Alcohol Drinking
Drinking Behavior
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18-25
* Be able to read English and complete study evaluations
* At least occasional heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) over the prior 30 days
* Frequent consumption of at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.

Exclusion Criteria:

* Severe substance use disorder
* Be psychotic or otherwise severely psychiatrically disabled
* Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)

Primary outcomes:
measure: Technology utilization
timeFrame: 4-week field use period
measure: Acceptability
timeFrame: 4-week field use period
measure: Usability
timeFrame: 4-week field use period
Secondary outcomes:
measure: Drinks per drinking day
timeFrame: 4-week field use period
measure: Estimated blood alcohol content
timeFrame: 4-week field use period
measure: Negative Consequences
timeFrame: 4-week field use period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Robert F Leeman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723462: How Often Are Pharmacist Recommendations Followed by Emergency Physicians in Emergency Departments?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacist Recommendations
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 301
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all acute admissions to emergency department

Brief summary: Clinical pharmacy has played a role in Emergency Departments (ED). The presence of pharmacists have been shown to reduce medication errors and improve the medication history taken at admission. In Denmark a recent study revealed that clinical pharmacists identified medication problems in 25% of all admission to the ED, of which 47 % were considered to be serious.

However, the pharmacist recommendations are of little value if they are not acknowledged or followed by the physicians.

The aim of the present study was to analyze how often and under which circumstances the physicians made use of pharmaceutical recommendations in an ED with a mixed patient population with special attention to those recommendations, which were of significant or disastrous importance.


Eligibility criteria: Inclusion Criteria:

- all acute admissions to emergency department who were treated with one or more drugs

Exclusion Criteria:

- children less than 15 years.

Primary outcomes:
measure: number of pharmacist recommendations
timeFrame: up to 48 hours after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Kolding Sygehus
Study officials:
References:
citation: Mogensen CB, Olsen I, Thisted AR. Pharmacist advice is accepted more for medical than for surgical patients in an emergency department. Dan Med J. 2013 Aug;60(8):A4682.
Clinical trial NCT06148662: The Effect of Oral Sprays on Salivary pH
Official title: The Effect of Oral Sprays on Salivary pH Changes After Coca-cola Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Health
Keywords: Coca-cola
salivary buffer capacity
salivary pH
oral foams
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults.

Detailed description: This will be a cross-over clinical trial assessing the effect of oral foams containing zink hydroxiapatite and probiotics (Lactobacillus, Bifidobacterium), Olaflur (amino fluoride), and oral spray with alkaline thermal water. The study will be conducted in six visits over a period of 1.5 months. After enrolment, dental examination will be performed using the following indices: DMFT, OHI-S index, Bleeding index. Saliva buffer capacity, salivary flow rate, and baseline salivary pH will be measured. Salivary pH changes will be registered after consumption of Coca-cola alone or followed by each of the tested products application.

Eligibility criteria: Inclusion Criteria:

* Females and males
* Aged between 18-44 years
* Willingness to comply with all study procedures and availability for the duration of the study.
* Subjects who signed informed consent

Exclusion Criteria:

* History of chemotherapy or radiotherapy;
* An oral mucosa pathology;
* Orthodontic treatment within the previous 3 months;
* Dental bleaching within the previous 3 months;
* Withdrawal of consent;
* Patient refusal to continue participation in the study;
* Detection of an allergic reaction to any components of the dental foams or carbonated drinks used in the study.

Primary outcomes:
measure: The time required for salivary pH recovery after Coca-Cola consumption
timeFrame: 1 hour
measure: The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application
timeFrame: 1 hour
measure: Minimal value of salivary pH after Coca-Cola consumption
timeFrame: 1 hour
measure: minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute of Dentistry of Sechenov University
Study officials:
References:
Clinical trial NCT02032862: Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating
Official title: Multicentric, Randomized, Double Blind Study for Assessment of Efficacy and Tolerability of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Menopausal Hot Flushes
Keywords: menopause, hot flushes, hot flashes, salvia, sage, sweating
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 107
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot flushes daily and a Hyperhidrosis Scale score ≥ 2


Eligibility criteria: Inclusion Criteria:

* Menopausal since ≥ 1 year
* ≥ 5 hot flushes /24 hours
* Hyperhidrosis Scale score ≥ 2

Exclusion Criteria:

* Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours

Primary outcomes:
measure: Change from Baseline Hyperhidrosis Disease Severity Scale
timeFrame: Week 12
Secondary outcomes:
measure: Change from Baseline Menopause Rating Scale / MRS
timeFrame: Week 12
measure: Change from Baseline Modified Dem Tect
timeFrame: Week 12
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Dr. M. Morger
state: St. Gall
Study officials:
References: