louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05253001: Effects of Antenatal Education on Maternal Childbirth
Official title: Effects of Antenatal Education on Maternal Childbirth Self-efficacy and Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Efficacy
Maternal Behavior
Keywords: maternal self-efficacy
maternal education
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: An experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants. The study groups mobile chatbot approach to improving prenatal education. The controp group was a traditional approach to prenatal education.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In prenatal education, pregnant women's knowledge is a crucial issue for protecting pregnant women and newborns healthy. Therefore, prenatal education has become a basic and essential program for each pregnant woman. However, most of the current prenatal education courses are taught via a group teaching approach, which makes it difficult for pregnant women to think deeply about relevant birth issues due to the lack of interaction and context. This may in turn have an impact on childbirth choice and clinical judgment.

Detailed description: My study Purpose wants to see doseThe mobile chatbot approach improve prenatal education shared decision-making. In order to verify the effectiveness of such a learning design, an experiment was developed in the current study. A total of 40 women from a medical hospital in northern Taiwan were recruited as the participants.

Eligibility criteria: Inclusion Criteria:

* Parturients who have come to the hospital for obstetrics

Exclusion Criteria:

* Parturients who have ever to the hospital for obstetrics

Primary outcomes:
measure: Effects of antenatal education on maternal childbirth self-efficacy and satisfaction
timeFrame: the outcome measure will be assessed through study completion and data will be reported up to 1 year.
measure: Effects of antenatal education on maternal childbirth self-efficacy and satisfaction
timeFrame: the outcome measure will be assessed through study completion and data will be reported up to 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05825001: Evaluating the Episodic Future Thinking Intervention for Reducing Cigarette Consumption in Cigarette Smokers
Official title: Pilot Study of Episodic Future Thinking Among Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial evaluates the effectiveness of active episodic future thinking (EFT) stimuli for reducing cigarette consumption in cigarette smokers. EFT is an innovative framing method shown to significantly activate brain regions involved in future thinking, planning, and other executive functions. Active EFT stimuli are positive events, unrelated to smoking, that participants anticipate, look forward to, and can vividly imagine happening up to 1 year in the future. Control EFT stimuli are positive past events, unrelated to smoking, that participants can vividly remember happening in the recent past. Active EFT stimuli may help reduce cigarette consumption among cigarette smokers by exposing them to personally relevant future oriented stimuli.

Detailed description: PRIMARY OBJEECTIVE:

I. To evaluate the efficacy of episodic future thinking (EFT) for smoking cessation.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (ACTIVE): Participants receive the active EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

ARM II (CONTROL): Participants receive the control EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

Eligibility criteria: Inclusion Criteria:

* Smoke \>= 10 cigarettes daily
* \>32 on the Vividness of Visual Imagery Questionnaire (VVIQ)
* No regular use of other tobacco products
* In possession of a smartphone with text messaging capabilities

  * Willing to quit smoking in the next 30 days
  * Low socioeconomic status
  * Veteran of the US armed services

Exclusion Criteria:

* Unable or unwilling to provide verbal consent
* Unable or unwilling to provide data to the research team
* Current use of nicotine replacement therapy, bupropion, or varenicline
* Use of drugs of abuse in the past 30 days
* Living in the same household as a participant already enrolled in this study
* Unable or unwilling to use nicotine patches

Primary outcomes:
measure: Concentration of carbon monoxide on breath
timeFrame: From baseline up to 30 days
Secondary outcomes:
measure: Reduction in delay discounting rate
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park
name: Christine Sheffer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00527501: IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma
ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-09-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria:

* Age (Under 18)

Primary outcomes:
measure: Mean IOP
timeFrame: Time
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Artesia
state: California
Study officials:
affiliation: Alcon Research
name: Theresa Landry
role: STUDY_DIRECTOR
References:
Clinical trial NCT02928601: Norepinephrine Consumption After Prophylactic Ondansetron
Official title: Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Maternal Hypotension
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.

Detailed description: Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia. The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II patients
* Between the ages of 18 and 40 years
* Scheduled for elective caesarean section with spinal anesthesia

Exclusion Criteria:

* History of hypertension
* History of severe hepato-renal disease,
* sensitivity or contraindication to ondansetron,
* Drug or alcohol abuse
* Contraindication to regional anesthesia.

Primary outcomes:
measure: Norepinephrine consumption
timeFrame: During the cesarean operation
Secondary outcomes:
measure: Bradicardia
timeFrame: During the cesarean operation
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University
Study officials:
affiliation: Çukurova University
name: Hakkı Ünlügenç, Professor
role: STUDY_DIRECTOR
References:
citation: Gao L, Zheng G, Han J, Wang Y, Zheng J. Effects of prophylactic ondansetron on spinal anesthesia-induced hypotension: a meta-analysis. Int J Obstet Anesth. 2015 Nov;24(4):335-43. doi: 10.1016/j.ijoa.2015.08.012. Epub 2015 Aug 22.
citation: Wang Q, Zhuo L, Shen MK, Yu YY, Yu JJ, Wang M. Ondansetron preloading with crystalloid infusion reduces maternal hypotension during cesarean delivery. Am J Perinatol. 2014 Nov;31(10):913-22. doi: 10.1055/s-0033-1364189. Epub 2014 Feb 10.
Clinical trial NCT06819501: Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs
Official title: Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancers
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues


Eligibility criteria: Inclusion Criteria:

1. Patients with newly diagnosed breast cancer by pathology
2. Age 18-60 years
3. ECOG 0-2
4. CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs

Exclusion Criteria:

1. Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and/or low body mass newborns.

   iv. Premature and/or low body mass neonates.
2. Other cancers

Primary outcomes:
measure: Difference in change in CIPN score due to paclitaxel analogues compared to baseline
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
Secondary outcomes:
measure: NPS degree
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: EORTC QLQ - CIPN20
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: ENS score
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: neuromyography
timeFrame: Baseline, 8 week
measure: life quality
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: insomnia score
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: depression score
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: Exhaustion score
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week
measure: Side effects of hyperbaric oxygen therapy
timeFrame: during the hyperbaric oxygen therapy (up to 2 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01741701: A Pilot Study of Oxaloacetate in Subjects With Treated PD
Official title: A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Terra Biological LLC
First posted: 2012-12-05
Enrollment: 33
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.


Eligibility criteria: Inclusion Criteria:

* Able to give informed consent and follow instructions per the protocol
* Diagnosis of idiopathic PD within 7 years of diagnosis
* Taking stable doses of levodopa and would not predictably need adjustment in PD medications for 4 months
* Unified Parkinson's Disease Rating Scale (UPDRS) II + III at least 30 points at baseline

Exclusion Criteria:

* Previously taken Oxaloacetate
* Participation in other drug studies or use of other investigational products within 30 days prior to baseline
* In the Investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up
* Other known or suspected cause of parkinsonism

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: 4 months
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score
timeFrame: 4 months
measure: Parkinson's Disease Questionnaire - 39 (PDQ-39)
timeFrame: 4 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 4 months
measure: Geriatric Depression Scale (GDS)
timeFrame: 4 months
measure: NonMotor Symptom Questionnaire (NMSQuest)
timeFrame: 4 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Rajesh Pahwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07008001: Assessment of DOT Spectacles in Chinese Children Extension
Official title: Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Myopia
Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 175
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.


Eligibility criteria: Inclusion Criteria:

1. Previously a successfully completed participant in the CATHAY study (NCT05562622)
2. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)
3. Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
4. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form

Exclusion Criteria:

1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate

Primary outcomes:
measure: Axial length Group I
timeFrame: 12 months
measure: Axial length Group II
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Aier Eye Hospital
city: Chengdu
country: China
facility: West China Hospital
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
city: Shanghai
country: China
facility: Fudan University EENT
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
Clinical trial NCT05481801: Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
Official title: Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All type 1 diabetes patients attendet at the Ciudad Real General University Hospital.

Brief summary: Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

Detailed description: Cross-sectional analysis about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

All clinical variables are gathered from two EMR softwares (Mambrino XXI and Turriano).

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Age: 18 yrs. or older

Exclusion Criteria:

* Other diabetes types.
* Younger than 18 years.

Primary outcomes:
measure: Vaccination adherence
timeFrame: 1 year and a half
Secondary outcomes:
measure: Sick Leaves
timeFrame: 1 year and a half
measure: Hospital admission
timeFrame: 1 year and a half
measure: Death
timeFrame: 1 year and a half
Other outcomes:
Locations:
city: Ciudad Real
country: Spain
facility: Ciudad Real General University Hospital
Study officials:
References:
citation: Moreno-Fernandez J, Garcia-Seco JA, Rodrigo EMO, Segura AMS, Garcia-Seco F, Munoz-Rodriguez JR. Vaccination adherence to influenza, pneumococcal and hepatitis B virus in adult type 1 diabetes mellitus patients. Prim Care Diabetes. 2020 Aug;14(4):343-348. doi: 10.1016/j.pcd.2019.09.004. Epub 2019 Sep 30.
citation: Giatraki V, Dimitriou H, Pappas A, Mamoulakis D, Makris G, Galanakis E, Perdikogianni C. Vaccine coverage in children, adolescents and adults with type 1 diabetes and their close contacts in Crete. Hum Vaccin Immunother. 2021 Nov 2;17(11):4291-4298. doi: 10.1080/21645515.2021.1973882. Epub 2021 Oct 6.
citation: Wang CH, Jones J, Hilliard ME, Tully C, Monaghan M, Marks BE, Hildebrandt T, Streisand R. Correlates and Patterns of COVID-19 Vaccination Intentions among Parents of Children with Type 1 Diabetes. J Pediatr Psychol. 2022 Aug 12;47(8):883-891. doi: 10.1093/jpepsy/jsac048.
Clinical trial NCT03746301: Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation
Official title: Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Keywords: Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2018-11-19
Enrollment: 924
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NVAF who have moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment, requiring rivaroxaban for the prevention of stroke or non-CNS systemic embolism. Patients must also meet all the eligibility criteria for the study.

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.


Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 19 years of age
* Diagnosis of NVAF
* Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
* Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
* Written informed consent of the patient

Exclusion Criteria:

* Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Planned treatment with other anticoagulants.
* Expected renal-replacement therapy within the next 3 months

Primary outcomes:
measure: Incidence proportion of major bleeding
timeFrame: Up to 12 months
Secondary outcomes:
measure: Occurrence of AEs and SAEs
timeFrame: Up to 12 months
measure: Occurrence of all-cause mortality
timeFrame: Up to 12 months
measure: Occurrence of Non-major bleeding
timeFrame: Up to 12 months
measure: Incidence proportion of Symptomatic thromboembolic events
timeFrame: Up to 12 months
measure: Days of rivaroxaban treatment
timeFrame: Up to 12 months
measure: The change in creatinine clearance from baseline
timeFrame: At month 3,6,9 and 12
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Many locations
Study officials:
References: