louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02695017: Changes in Oxygen Saturation in Two Exercise Modalities
Official title: Comparison of Changes in Oxygen Saturation in Flywheel Exercise Versus Conventional Strength Machine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Oxigenation
Strength
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigator will proceed to assess changes in oxygenation of muscle tissue, electromyographic activation and strength in healthy subjects. For this, a measurement of all demographic variables on the first day of the study as well as a familiarity with the equipment will be performed. Participants will start the intervention 48 hours later to proceed with the first intervention with one of the exercises in this research (inertial pulley or regular machine). Later on, 48 hours later participants will perform the latest intervention that has not yet done, thus generating a crossover study.


Eligibility criteria: Inclusion Criteria:

* Sedentary
* No pain
* Non disease

Exclusion Criteria:

* Exercise experience

Primary outcomes:
measure: Percentage of Oxygen saturation of Vastus lateralis muscle during the exercise of each participant
timeFrame: one second
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Superior de Estudios Universitarios La Salle
Study officials:
affiliation: Centro La Salle Universitario
name: Daniel Muñoz, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074541: The Vitamin D Dose-Response Relationship
Official title: Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Status
Keywords: Vitamin D
UVB
Dose-Response
UV intensity
Skin cancer
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2010-02-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.

Detailed description: The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships.

Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.

Eligibility criteria: Inclusion Criteria:

* 18-65 years
* Healthy

Exclusion Criteria:

* Sun bed use
* Holiday or business travel south of 45 degrees latitude during trial
* Illness
* Drug addiction
* Pregnancy
* Lactating

Primary outcomes:
measure: Vitamin D (nmol/l)
timeFrame: 2 days after exposure
Secondary outcomes:
measure: Other parameters
timeFrame: 2 days after radiation
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital, Department of Dermatology
state: NV
Study officials:
affiliation: Bispebjerg Hospital, Deparment of Dermatology
name: Hans Christian Wulf, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04409041: Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Official title: Oral Low-Dose Naltrexone in the Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia; an Uncontrolled Open-label Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lichen Planopilaris
Frontal Fibrosing Alopecia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. A recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. There were no reported adverse events.

Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 or greater
* clinically or histologically confirmed diagnosis of lichen planopilaris or frontal fibrosing alopecia

Exclusion Criteria:

* known allergy or hypersensitivity to naltrexone
* patients with concurrent use of opioids
* active depression, schizophrenia, and bipolar disorder

Primary outcomes:
measure: Change in Patient-Reported Itch
timeFrame: 12 months
measure: Change in Investigator Rated Erythema
timeFrame: 12 months
measure: Patient Reported Burning/Pain
timeFrame: 12 months
measure: Change in Investigator Rated Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT06520241: The Effect of Stress, Anxiety, and Depression Experienced by Pregnant Women on Sleep Bruxism and Oral Health
Official title: The Effect of Stress, Anxiety, and Depression Experienced by Pregnant Women on Sleep Bruxism and Oral Health: Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Bruxism, Adult
Stress
Depression
Anxiety
Pregnancy Related
Oral Disease
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 321
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background The oral health of pregnant women affects not only the systemic health of the mother but also the birth outcome of the fetus. Therefore, oral health management of pregnant women is important for both maternal and fetal health.

Objectives The study aimed to examine the effects of stress, anxiety, and depression experienced by pregnant women on sleep bruxism and oral health.

Methodology This cross-sectional study was conducted between September and November 2023 on 321 pregnant women who volunteered to participate in the study by posting on social media forum pages via the web. Data were collected using the Personal Information Form, Depression-Anxiety-Stress Scale (DASS-21), and Oral Health Impact Scale (OHIP-14-TR). Descriptive statistical methods, the Kruskal-Wallis test, Mann-Whitney-U test, and Spearman correlation test were used to analyze the data.


Eligibility criteria: Inclusion Criteria:

* Pregnant women over the age of 18 who were pregnant, diagnosed with sleep bruxism, and who could read and write were included in the study.

Exclusion Criteria:

* Women who refused to participate in the study, who could not be contacted, who had serious dental health problems in the last six months, who had dentures, who had serious stress disorder in the last six months, who filled out the data collection form incompletely, who had hearing-vision problems or intellectual disability, and who had diagnosed psychological illness were not included in this study.

Primary outcomes:
measure: Depression-Anxiety-Stress Scale
timeFrame: 1 day (collected once)
measure: Oral Health Impact Scale
timeFrame: 1 day (collected once)
Secondary outcomes:
Other outcomes:
Locations:
city: Bartin
country: Turkey
facility: Bartın University
Study officials:
References:
Clinical trial NCT01477541: Cluster-randomized Trial Measuring Integration of Professional Midwives and Obstetric Nurses in Rural Clinics in Mexico
Official title: Incorporation of Alternative Providers for Care During Pregnancy, Delivery and Postpartum in Rural Public Health Clinics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Prenatal care
Maternal mortality
Perinatal mortality
Perinatal
Puerperium
Puerperium care
Midwives
Midwife
Obstetric
Nurse
Integration
Alternative personnel
Skilled attendant
Birth attendant
Delivery
Delivery services
Best practices
Rural
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Mexican National Institute for Women
name: Mexican Center for Gender Equity and Reproductive Health
name: Secretary of Health, Guerrero state
name: Secretary of Health, Oaxaca state
First posted: 2011-11-22
Enrollment: 27
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. This project uses an innovative strategy of integrating professional midwives and licensed obstetric nurses into rural medical centers in the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and puerperium care. The goal of the research is to increase use of best practices in intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and improve maternal and neonatal outcomes. We posited that medical centers receiving the intervention would provide better care and have better maternal and neonatal outcomes than those that did not receive the intervention.


Eligibility criteria: Inclusion Criteria:

* Clinics containing one medical team only (1 doctor and accompanying staff)
* Clinics less than 2 hours away from a referral hospital
* Clinics where at least 25 deliveries took place in the previous year

Exclusion Criteria:

* Clinics inaccessible by car
* Clinics undergoing remodeling

Primary outcomes:
measure: Use of evidence-based practices during labor, delivery, and postpartum care
timeFrame: 21 months
measure: volume of prenatal visits, deliveries
timeFrame: 21 months
measure: Use of harmful or unnecessary practices during labor and delivery
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Salud Publica, Mexico
name: Dilys Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00353041: A Study of the Effect of Time on Topical Anesthetic Efficacy.
Official title: A Study of the Effect of Time on Topical Anesthetic Efficacy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: topical
anesthetic
pain
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2006-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: This is a study of the effect of time on the effectiveness of topical anesthetics in the mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period, there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic administration.

Detailed description: The study design will be a double blind randomized controlled split-mouth clinical trial. It is proposed to compare the effectiveness of the standard topical anesthetic 5% lidocaine with a placebo over the time period of 2, 5 and 10 minutes after application. The topical will be placed on the palatal soft tissue where the perception of pain is the highest in the oral cavity. Both the pain of needle insertion and the pain of local anesthetic injection will be compared.

Eligibility criteria: Inclusion Criteria:

1. In good health (ASA 1 or ASA 2)
2. Weight between 40-100kg, inclusive.
3. Between ages 18-70, inclusive.
4. Informed consent

Exclusion Criteria:

1. ASA 3 or higher.
2. History of allergy to sulfites, lidocaine or mepivacaine.
3. Taking any analgesic 48hrs before testing, such as an NSAID, opioid, or acetaminophen.
4. Pregnancy.
5. Recent oral trauma.
6. Lack of informed consent.

Primary outcomes:
measure: pain
Secondary outcomes:
measure: Heart rate
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Faculty of Dentistry
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel A Haas, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03584841: Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test
Official title: Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test: Value for Diagnosis and Efficacy of Target Therapies for Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mucoviscidosis Involving the Lung
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Model: Three Group Assignment
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to implement a non-invasive version of the sweat secretion test based in visualization of sweat glands following β-adrenergic stimulation of sweat. Specifically, the trial will evaluate the relative response of sweat glands to β-adrenergic and cholinergic stimulation among participants with CF, heterozygous and matched control subjects


Eligibility criteria: Inclusion Criteria:

* For patients with cystic fibrosis: clinically stable, all genotypes included.
* For healthy volunteer and heterozygous subjects: 18 years and older.

Exclusion Criteria:

* Corticosteroids, anti-leukotriene therapy, unstable clinical status, \<40% FEV1.
* Current pregnancy or breastfeeding.

Primary outcomes:
measure: Ratio between the β-adrenergic/cholinergic rate
timeFrame: up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01482741: Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging
Official title: Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colon Cancer
Lung Cancer
Neuroblastoma
Testicular Cancer
Keywords: Quality of Life
Focus groups
Risks of Ionizing Radiation
Risk of medical imaging
11-185
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinical practices at MSKCC.

Brief summary: Risks from imaging-related radiation exposure have become a popular topic in the media. Because these tests are commonly applied to patients at a cancer center, it is important to understand what patients know, how they feel about what they know, where they get their information, and how satisfied they are with available risk-benefit communication on this topic.

The purpose of this study is to understand how cancer patients perceive risks and benefits of diagnostic radiation and their satisfaction with healthcare communication on this topic.


Eligibility criteria: Inclusion Criteria:

* English-language fluent
* 18 years of age, or older
* Provide informed consent
* Group 1: Patients undergoing chemotherapy for Stage IV colorectal carcinoma.
* Group 2: Parents of pediatric patients who have undergone treatment for stage 1-3 neuroblastoma.
* Group 3: Women who have undergone treatment for early stage breast cancer within the preceding 6 months.
* Group 4: Men undergoing surveillance imaging after treatment for testicular cancer.
* Group 5: Patients currently or previously enrolled in the MSKCC lung cancer screening program.
* Group 6: Patients enrolled in or eligible for the thoracic survivorship program.

Exclusion Criteria:

* Participants who don't speak English

Primary outcomes:
measure: characterize participant knowledge, attitudes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Raymond Thornton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00897741: Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer
Official title: Gene Expression Profiles in Primary and Metastatic Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer clinic

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells with metastatic tumor cells in patients with metastatic pancreatic cancer.

Detailed description: OBJECTIVES:

* Compare the gene expression profiles of pancreatic cancer cells from the primary and metastatic sites in patients with metastatic pancreatic cancer.
* Characterize the function of the differentially upregulated and downregulated genes identified by comparing the gene expression profiles of primary and metastatic cells in these patients.

OUTLINE: Fresh biopsy samples are collected for gene expression profiling and other biomarker/laboratory analyses.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of pancreatic adenocarcinoma of exocrine origin
* Metastatic disease
* Fresh biopsy material available from primary site of disease and a metastatic focus, including liver, peritoneum, or lymph node

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for pancreatic cancer

Primary outcomes:
measure: Gene expression profiles
timeFrame: at time of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Philip A. Philip, MD, PhD, FRCP
role: STUDY_CHAIR
References:
Clinical trial NCT00373841: Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis (IPF)
Official title: Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Lung
Fibrosis
Idiopathic
Biomarkers
Genomics
Longitudinal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 and older who have been diagnosed with IPF and referred by a Simmons Center doctor.

Brief summary: The purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or when patients are likely to experience a rapid decline in lung function due to disease progression.

Detailed description: People who are diagnosed with idiopathic pulmonary fibrosis are asked to participate in this study. The subject must be treated at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Subjects, if consented, are required to perform tests so that research data can be collected. At the initial visit, patients are subject to having a blood draw, pulmonary function testing, echocardiograms, and CT scans as well as completing several questionnaires designed to measure how the patient is feeling. Follow up visits are then scheduled in 3-4 month intervals. Every 3-4 months blood samples will be collected while every 6-8 months the questionnaires will administered. If the patient enters a stage of accelerated decline in lung function, a bronchoscopy will be performed to collect residual bronchoalveolar lavage fluid for testing. All of the results of clinical and laboratory testing will be placed into the subjects research file.

Eligibility criteria: Inclusion Criteria:

* Patients who are 18 or older
* Diagnosis of Idiopathic Pulmonary Fibrosis
* Treated at the Simmons Center

Exclusion Criteria:

* Other Lung Illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Michelle F MacPherson
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
name: Kevin F Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.