louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03441321: Social-Media Intervention in Reducing Tanning in High-Risk Tanners
Official title: Randomized Trial of a Social Media-Delivered Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Status Unknown
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-22
Enrollment: 407
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized clinical trial studies how well social-media intervention works in reducing tanning in high-risk indoor and outdoor tanners. Social-media intervention delivered via Facebook may help to promote healthy behaviors, positive body image, and to understand young women's perception of a social media campaign.

Detailed description: PRIMARY OBJECTIVES:

I. To conduct a randomized control trial to examine the efficacy of the intervention versus (vs.) a Facebook-delivered control group on reducing tanning behavior among high-risk indoor and outdoor tanners.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants periodically read the content on the study-specific secret Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks.

GROUP II: Participants participate in secret Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks.

After completion of study, patients are followed up at 3, 8, and 18 months post baseline assessment.

Eligibility criteria: Inclusion Criteria:

* High-risk indoor or outdoor tanner (defined as using an indoor tanning bed or intentionally tanning outdoors at least 10 times in the previous 12 months)
* Use of Facebook at least 4 times per week

Primary outcomes:
measure: Number of indoor or outdoor tanning sessions assessed using surveys
timeFrame: At 8 months
Secondary outcomes:
measure: Indoor and outdoor tanning behavior assessed using surveys
timeFrame: At 18 months
measure: Skin burns from indoor and outdoor tanning assessed using surveys
timeFrame: At 8 months
measure: Tanning intentions assessed using surveys
timeFrame: At 8 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jerod Stapleton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03234621: Protective Ventilation Strategy
Official title: Protective Ventilation Strategy During One-lung Ventilation: Effect on Postoperative Pulmonary Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One-lung Ventilation
Keywords: protective ventilation strategy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective thoracic surgery
* ASA I, II, III
* scheduled \> 2 hours of surgery

Exclusion Criteria:

* denied patients
* age under 18 years
* FEV1/FVC or FEV1\<70% in preoperative pulmonary function test

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: immediately after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06268821: Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland
Official title: The Effect on HbA1c of the Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 11
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: OTHER

Brief summary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

Detailed description: This is a post-market, multi-centre, prospective, interventional single arm study in Finland.

Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.

HbA1c will be tested at the start and end of the study for primary endpoint analysis.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 to ≤ 75 years.
* Type 2 diabetes diagnosis ≥1 year prior to enrolment.
* Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
* Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
* Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.

Exclusion Criteria:

* Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
* Currently participating in another study that could affect glucose measurements or glucose management.
* Currently receiving dialysis treatment or receives dialysis during the study.
* A female participant who is pregnant.
* A breastfeeding female participant.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Time in range (TIR)
timeFrame: 3 months
measure: Time above range (TAR)
timeFrame: 3 months
measure: Time below range (TBR)
timeFrame: 3 months
measure: Frequency of hypoglycaemia events
timeFrame: 3 months
Other outcomes:
Locations:
city: Jämsä
country: Finland
facility: Pihlajalinna Jämsä, Välikatu 1,
city: Tampere
country: Finland
facility: Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1,
Study officials:
affiliation: Pihlajalinna, Jämsä
name: Henri Honka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04818021: Contribution of the Somatosensory System to Speech Perceptual Processing
Official title: Contribution of the Somatosensory System to Speech Perceptual Processing Aim 3
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Speech
Consolidation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: McGill University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-03-26
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: These studies test the hypothesis that the repeated pairing of somatosensory inputs with speech sounds, such as occurs during speech motor learning, results in changes to the perceptual classification of speech sounds.

Detailed description: This study will assess changes to the perceptual classification of speech sounds that are related to repeated pairing of somatosensory and auditory inputs (as would occur during speech motor learning). Before and after the training, base-line and post-training auditory perceptual performance will be examined in the absence of somatosensory stimulation, in order to evaluate the effects of the pairing on speech perception. Perceptual classification and speech motor learning will both be assessed on a 0 to 100 scale.

Eligibility criteria: Inclusion Criteria:

* right handed adults
* no known physical or neurological abnormalities

Exclusion Criteria:

* patients with:
* cardiac pacemaker
* surgical clips or values on the heart
* implants
* metal or metallic fragments in any part of the body
* pregnancy
* claustrophobia
* a personal or family history of epilepsy
* currently taking antipsychotic drugs
* currently taking antidepressant drugs
* currently taking antianxiety drugs.

Primary outcomes:
measure: Speech Motor Learning
timeFrame: Performance as measured at the end of learning (30 minute session)
measure: Speech Perception
timeFrame: Perception is evaluated prior to and after perceptual training (30 minute session)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Haskins Laboratories
name: David Ostry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441721: Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient
Official title: Vitamin b12 Deficency and Its Impact on Chronic Haemodialysis Patient and Its Effect on Anemia and Neuropathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: End Stage Renal Disease on Dialysis
Vitamin B 12 Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: evaluate vitamin b12 in serum in chronic haemodialysis patient not diabetic age group 18-80 years

Brief summary: To evaluate vitamin B12 level in haemodialysis patients and its impact on hematological and neurological manifestations

Detailed description: Vitamin B12 (cobalamin) is a water-soluble vitamin involved in several normal cellular functions (1). Vitamin B12 is required for the development, myelination, and function of the central nervous system; healthy red blood cell formation; and DNA synthesis (2- 4). Low levels of vitamin B12 have been associated with high concentrations of homocysteine (Hcy) and can lead to health complications (5). Hyperhomocysteinemia is an important risk factor for cardiovascular disease (6). Vitamin B12 and other B vitamins are involved in homocysteine metabolism, and researchers have hypothesized that supplementation with these micronutrients can reduce the risk of cardiovascular disease by lowering homocysteine levels (7, 8). Vitamin B12 deficiency is one of the causes of Macrocytic anaemia with increased mean corpuscular volume (MCV), defined as more than 100 fL, which is the hallmark of megaloblastic anaemia

Eligibility criteria: Inclusion Criteria:

* End stage renal disease on haemodialysis pts.
* Parients more than 18 years .
* CKD patients controled group stage 3and stage 4.

Exclusion Criteria:

* Recent renal transplantation patients.
* Patients on sulpha drugs.
* Patients on methotrexate.
* Patients on anticonvulsant.
* Patients on chemotherap agent.
* Patients on colchicine.
* Patients on bile acid sequestrant.
* Patients on h2blockers.
* Patients on metformin.
* Patients on proton pump inhibitors .
* Diabetic patients.
* Parients with history of intestinal surgery.
* Patients diagnosed with malabsorption syndrome.
* Patient on vitamin b12 intake.

Primary outcomes:
measure: vitamin b12 in serum
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Juszczak AB, Kupczak M, Konecki T. Does Vitamin Supplementation Play a Role in Chronic Kidney Disease? Nutrients. 2023 Jun 23;15(13):2847. doi: 10.3390/nu15132847.
citation: Fahndrich C, Gemperli A, Baumberger M, Harder M, Roth B, Schaefer DJ, Wettstein R, Scheel-Sailer A. Risk factors of major complications after flap surgery in the treatment of stage III and IV pressure injury in people with spinal cord injury/disorder: a retrospective cohort study. Spinal Cord. 2024 Jan;62(1):34-41. doi: 10.1038/s41393-023-00944-9. Epub 2023 Dec 20.
Clinical trial NCT00217321: Parkinson's Disease Registry of the Muhammad Ali Parkinson Center
Official title: Parkinson's Disease Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Parkinson disease
Registry
quality of life
database
Lead sponsor: Muhammad Ali Parkinson Research Center
Sponsor class: OTHER
Collaborators: name: Barrow Neurological Foundation
First posted: 2005-09-22
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be over 18 years old, have idiopathic Parkinson's disease diagnosed by a physician.

Brief summary: The purpose of the Parkinson's disease Registry is to develop a national and international database of persons with Parkinson's disease (PD). The Registry will be used to facilitate the development of new therapies and healthcare services to improve the quality of life for people with PD. It will also be a means for investigators in the field of PD to quickly identify and notify subjects about other research studies for which they are eligible.

Objectives include:

* Assess current treatment approaches and develop best-practice guidelines
* Track the functional abilities, access to healthcare and cost of illness of people with PD over time
* Drive the development of innovative research projects
* Accelerate the process of informing patients of research projects for which they may be eligible

Detailed description: What do you need to know?

* Any individual diagnosed with PD is eligible to enroll.
* Participation in the registry is voluntary, confidential and free of charge.
* Eligible participants will be notified about opportunities to participate in clinical trials, though they are under no obligation to enter.
* Participants will need to complete an updated questionnaire every six months.
* Participants may also be asked to complete additional surveys for PD research projects.
* Any data provided will be used in scientific publications in summary form only.
* Participant names will not be released to anyone outside the Parkinson's disease Registry management team without written authorization, nor will names be sold for advertising or fund-raising purposes.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* No clinical diagnosis of Parkinson's disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Muhammad Ali Parkinson Research Center
state: Arizona
Study officials:
affiliation: MAPC
name: Abraham Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01738321: Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery lasting longer than 4 hours.

Brief summary: To date, there are no data in the literature regarding changes in the intracuff pressure during prolonged surgical procedures. It is possible that the pressure will increase over time related to gas expansion during equilibration to body temperature. If this is the case, these patients may be at risk for tracheal damage. This is a prospective study to evaluate the changes in intracuff pressure over time during prolonged surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Patients in whom a cuffed endotracheal tube is to be used for surgical procedures of more than 4 hours.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Intracuff Pressure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Kako H, Alkhatib O, Krishna SG, Khan S, Naguib A, Tobias JD. Changes in intracuff pressure of a cuffed endotracheal tube during surgery for congenital heart disease using cardiopulmonary bypass. Paediatr Anaesth. 2015 Jul;25(7):705-10. doi: 10.1111/pan.12631. Epub 2015 Mar 4.
Clinical trial NCT01798121: Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)
Official title: A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tuberculosis Identification.
Keywords: PPD
Tuberculosis
Lead sponsor: JHP Pharmaceuticals LLC
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2013-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A study to determine bioequivalence of PPD material versus Reference Standard.

Detailed description: This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).

Eligibility criteria: Inclusion Criteria:

1. Males or nonpregnant females age 18 to 60 years
2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc
3. Give written informed consent to participate
4. Generally healthy, as determined by medical history and targeted physical examination, if indicated
5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar
6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina

Exclusion Criteria:

1. Prior PPD test within the past 30 days
2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in
4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is
5. Presence of conditions that may suppress TST reactivity -

Primary outcomes:
measure: Compare new PPD to Reference Standard
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04487821: EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS
Official title: EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Keywords: Traumatic Brain Injury
Concussion
Vestibular Rehabilitation Therapy
Football
Balance
Lead sponsor: Zohra Institute of Health Sciences
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic brain injury (TBI) is one and utmost rampant attained neurological conditions which can happen in young adults. Vestibular Rehabilitation Therapy can help them improve their balance, speed and agility.

Detailed description: Total 40 sample size out of which were divided into control and experimental group. Concussed football athletes with age ranging 15-25 year, those participating actively in the sports were included in the study in the region of Kyber Pukhtoonkhwa Peshawar.

Eligibility criteria: Inclusion Criteria:

Active Male football player. Age between 15-25 years. Known cases of concussion were included in the study. Those patients complaining mild vertigo \& participating in sports

Exclusion Criteria:

Concussion other than sports. History of metabolic diseases. History of recent fractures.

Primary outcomes:
measure: Balance
timeFrame: upto 8 weeks
measure: Agility
timeFrame: upto 8 weeks
measure: Speed
timeFrame: upto 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Syed Alamdar Hussain
state: KP
Study officials:
References:
Clinical trial NCT00040521: Study Evaluating rhIL-11 in Active Crohn's Disease
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Inflammatory Bowel Disease
Keywords: Crohn's Disease
Active Crohns Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-28
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index \[CDAI\] score from 220-400).


Eligibility criteria: Inclusion Criteria:

* Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
* Men and women age 16 years and over.
* Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease)

Exclusion Criteria:

Use of the following medications within the specified time period prior to randomization:

* Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 \[COX-2\] inhibitors and \>500 mg/day acetylsalicylic acid)
* Codeine-containing compounds
* Corticosteroid enemas

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arvada
country: United States
state: Colorado
city: Chapel Hill
country: United States
state: North Carolina
Study officials:
affiliation: clinicaltrialinfo@wyeth.com
name: Medical Monitor
role: STUDY_DIRECTOR
References: