louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01619995: Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
Official title: Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urge Urinary Incontinence
Keywords: urge incontinence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-06-15
Enrollment: 43
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women over 60 years

Brief summary: The goal of this project is to evaluate the applicability of non-invasive optical imaging for the measurement of brain function during investigation of the lower urinary tract.


Eligibility criteria: Inclusion Criteria:

* ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes.
* urinary incontinence (urge or predominantly urge) by clinical criteria.
* able to accurately complete a voiding diary, to perform a 24-hour pad test under direction.

Exclusion Criteria:

* significant mental impairment \[mini mental status exam (MMSE) ≤ 20)
* urethral obstruction
* history of bladder cancer
* spinal cord lesions
* multiple sclerosis
* pelvic radiation
* interstitial cystitis
* artificial sphincter implant
* expected to have changes in medications/doses during the trial
* medically unstable
* Patients with factors that could cause transient UI \[e.g., current urinary tract infection (UTI), acute confusion\] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
* conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Geriatric Continence Research Unit, NE547 Montefiore UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Werner Schaaefer, DI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06714695: A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients
Official title: Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Black Stains
Keywords: Black stains
chromogenic
Children
Pediatric
Recurrence
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Misr International University
First posted: 2024-12-04
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:

Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?

Participants will:

Take chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection


Eligibility criteria: Inclusion Criteria:

* 1. Cooperative child to be able to perform and tolerate different oral hygiene procedures 2. Parents providing informed consent 3. Accept 18 weeks follow up period 4. Teeth showing black stains without calculus.

Exclusion Criteria:

* 1. Patients with Allergic reactions to food \& drugs containing derivatives from crustacean organisms. 2. Taking any antibiotic drugs within 2- week period before sample collection. 3. Taking any dietary supplements containing iron. 4. Teeth selected should be free of caries 5. Free of any developmental defects

Primary outcomes:
measure: Recurrence of Black stains
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine Azhar University
Study officials:
References:
citation: Milleman KR, Creeth JE, Burnett GR, Milleman JL. A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation. J Esthet Restor Dent. 2018 Mar;30(2):E45-E51. doi: 10.1111/jerd.12355. Epub 2018 Feb 7.
citation: Qin C, Li H., Xiao Q, Liu Y, Zhu J, Du Y. Water-solubility of chitosan and its antimicrobial activity, Carbohydr Polyr 2006; 63:367-74.
citation: Koch MJ, Bove M, Schroff J, Perlea P, Garcia-Godoy F, Staehle HJ. Black stain and dental caries in schoolchildren in Potenza, Italy. ASDC J Dent Child. 2001 Sep-Dec;68(5-6):353-5, 302.
Clinical trial NCT04407195: COVID-19 and Mental Health
Official title: Mental Health Outcomes Among US Healthcare Workers Exposed to COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Mental Health Disorder
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include physicians and nurse who interact with patients with known or suspected COVID-19.

Brief summary: The overall objective of this study is to assess the enormity of mental health outcomes among healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the pandemic in the United States, specifically targeting those areas most effected.

Detailed description: Healthcare providers (nurses and physicians) on the frontlines of the COVID-19 response are facing a critical situation and are subject to increased psychological distress. Those directly involved in the diagnosis, treatment and care of patients with COVID-19 are at significant risk of developing physical, psychological, and psychosocial distress.

The data examined in this study will further clarify the mental distress experienced by healthcare workers and lead to the development of peer-support and educational initiatives to improve these findings. The central hypothesis of this research is that high levels of mental distress will be associated with caring for patients with COVID-19.

This study will use an observational, cross-sectional on-line survey design. Participants will complete a 15 minute self-administered questionnaire. All data will be de-identified.

Eligibility criteria: Inclusion Criteria:

* Healthcare providers (physicians and nurse) working in institutions with known or suspected COVID-19.

Exclusion Criteria:

* Nurses and physicians who are retired, or not currently employed or not working in an environment with known or suspected COVID-19.

Primary outcomes:
measure: Emotional Impact
timeFrame: 7 days
Secondary outcomes:
measure: Depression
timeFrame: 2 weeks
measure: Anxiety
timeFrame: 2 weeks
measure: Insomnia
timeFrame: 1 week
measure: Resilience
timeFrame: 2 Weeks
measure: Crisis Support Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
References:
Clinical trial NCT01211795: Topical Intra-Oral Ketoprofen for Migraine Prevention
Official title: Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Prevention
Treatment
Ketoprofen
Trigeminal nerve
Lead sponsor: Behar, Caren, M.D.
Sponsor class: INDIV
First posted: 2010-09-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.

Detailed description: This is a 4 month trial. During the first month, a prospective headache diary is maintained. Migraine frequency, severity (1-10), duration, and all headache medications are recorded.

Patients are then randomized to receive active gel or placebo gel in double blind fashion.

Gel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as outlined above, is maintained throughout the trial. Patients may continue to take other migraine medications, as needed. No other new migraine therapies may be started during the trial.

Eligibility criteria: Inclusion Criteria:

* IHS Migraine with or without aura
* 18 y.o. or older
* at least 4 migraines per month

Exclusion Criteria:

* pregnancy
* other headache conditions
* chronic daily headache
* allergy or sensitivity to NSAIDs other severe illnesses

Primary outcomes:
measure: Change in number of migraine days per month
timeFrame: 3 months
Secondary outcomes:
measure: Change in migraine severity
timeFrame: 3 month total
measure: Change in migraine duration
timeFrame: 3 months
measure: Change in headache medication use
timeFrame: 3 months
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Caren Behar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04741295: Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome
Official title: To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenomyosis
Assisted Reproductive Technology
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. The purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.


Eligibility criteria: Inclusion Criteria:

1. The basal serum level of FSH was less than 10 IU / L
2. Diagnosed with adenomyosis by ultrasound
3. The first frozen thawed embryo transfer cycle, by hormone replacement protocol
4. Transfer at least one high quality frozen embryo;
5. Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.

Exclusion Criteria:

1. With abnormal karyotype;
2. Accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium \< 8mm on the day of transformation, etc;
3. PCOS, RIF patients;
4. There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;
5. There were contraindications to hormone replacement therapy and low molecular weight heparin;
6. Participating in other clinical studies;
7. Unable to follow-up

Primary outcomes:
measure: Early spontaneous abortion rate
timeFrame: Within three months after frozen embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT06680895: FeNO Observation Study in ICU Patients With ARS
Official title: An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients with advanced respiratory support

Brief summary: 1. Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU.
2. Secondary Purpose:

   1. To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time;
   2. The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;
   3. Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;
2. The expected mechanical ventilation time of tracheal intubation is more than 24 hours;
3. The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2;
4. Agree to participate in this experiment and sign the informed consent.

Exclusion Criteria:

* 1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement; 2. Participating in other clinical research projects; 3. Patients deemed unsuitable by the investigators.

Primary outcomes:
measure: FeNO concentration
timeFrame: 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ming Zhong, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06047795: Endurance Training in Patients With Post-TB Lung Disease
Official title: Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Post-Tuberculous Pleural Fibrosis
Post-Tuberculous Bronchiectasis
Keywords: Endurance training
Functional Capacity
Post-TB lung disease
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. There is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-TB complications.

Detailed description: Adults with post-TB respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. Such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. People with Chronic Respiratory Diseases frequently avoid exercise, which causes them to lose motivation and decondition. This cycle of decline continues. In Pakistan, there is no concept of pulmonary rehabilitation for TB patients. The current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in Pakistan.

Eligibility criteria: Inclusion Criteria:

* TB (diagnosed) with Completed TB course
* Dyspnea (with or without cough)
* Age (18-50yrs).
* After 3 months of AFB and gene expert (-)
* Decreased PFT predicted values

Exclusion Criteria:

* Smoker, Diabetes, and cardiac patients
* Physical disabled, pregnant (lactating women)
* Sputum + testing for TB
* Gene expert
* CVD (unstable)
* Not willing to participate

Primary outcomes:
measure: Functional capacity
timeFrame: 3 weeks, 6 weeks
measure: Dyspnea
timeFrame: 3 weeks, 6 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 3 weeks,6 weeks
measure: Forced vital Capacity (FVC)
timeFrame: 3 weeks,6 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 3 weeks,6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Green Star NGO
state: KPK
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT-CPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06904495: Assessment of Sleep Quality in Patients Treated for Cancer Between 15 and 24 Years of Age
Official title: Assessment of Sleep Quality in Patients Treated for Cancer Between 15 and 24 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivors
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Medical professionals now take into account the specificities of the care and support of Adolescents and Young Adults (AYAs). Cancer aftermaths in patients diagnosed during the AYA period are also known: the consequences of chemotherapy and radiotherapy treatments on a growing organism, the difficulty of some follow-ups, the longevity, and the delayed occurrence of certain complications.

In the general population, sleep disorders affect 40% of adolescents. About 30% of pediatric cancer survivors experience fatigue they attribute to their cancer, even years after the end of their treatment. The sleep quality of patients treated for cancer when they were AYAs, and the eventual care of sleeping disorders, are poorly studied. The investigators suppose that the oncologic treatment during this particular life stage, when sleeping disorders are already present and multifactorial, could have long-term impacts on sleep. The investigators offer to evaluate, through a questionnaire filled out by patients treated for cancer in the AYA period, the frequency of moderate to severe insomnia.


Eligibility criteria: Inclusion Criteria:

* Patient treated for a cancer
* Patient aged between 15 and 24 years old at the time of the diagnosis
* Patients whom intensive treatment ended at least 3 months ago
* Patient followed in a PACAAURA cancerology center
* Life expectancy ≥ 6 months
* Karnosky index \> 60%
* Patient who agrees to participate in the program and benefits from social security
* Patient able to understand, speak and read French.
* No major cognitive impairment (assessed by the patient's referees)
* No sensory disability

Exclusion Criteria:

* Patient unable to use informatic tools
* Known superior cognitive function disorders
* Progressive psychiatric pathology
* Drug user or alcohol abuse

Primary outcomes:
measure: Number of patients presenting moderate or severe insomnia
timeFrame: Day 1
Secondary outcomes:
measure: Identification of sleep disorders risk factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT05345795: Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis
Official title: Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis
Interstitial Lung Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic sclerosis-interstitial lung disease

Brief summary: Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Disease course in SSc-ILD is highly variable: patients can experience stable disease, slow or fast progression. Prevention of ILD progression now represents a key objective of SSc-ILD management. The understanding of the course and patterns of SSc-ILD progression is necessary, as reliable prediction tools that allow the stratification of the risk of progression. We aimed to identify the longitudinal trajectories of ILD in SSc patients using latent class mixed models and to examine their associations with SSc characteristics.


Eligibility criteria: Inclusion Criteria:

* Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
* Patients with interstitial lung disease on HRCT chest
* Patients with PFT at ILD diagnosis and at least 1 PFT evaluation during follow-up

Exclusion Criteria:

* Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

Primary outcomes:
measure: FVC change over time
timeFrame: at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis
Secondary outcomes:
measure: DLCO change over time
timeFrame: at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis
Other outcomes:
Locations:
city: Vandoeuvre-lès-nancy
country: France
facility: CHU Nancy
state: Grand Est
Study officials:
References: