louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03826225: Cardiac Monitor Employee Study
Official title: Cardiac Monitor Employee Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll volunteer adult participants who are employees of the study sponsor and who meet all eligibility criteria.

Brief summary: This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.

Detailed description: The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data generated by the wearable cardiac monitor.

Eligibility criteria: Inclusion Criteria:

* Willing and capable to provide informed consent
* Age 18 or above
* Employee of the study sponsor
* Willing and able to follow protocol requirements

Exclusion Criteria:

* Currently enrolled in another clinical study that interferes with data collection
* Currently implanted with an active medical electronic device
* Known allergies to the materials that may come in contact with the skin
* Any active skin condition on the chest reported by the subject

Primary outcomes:
measure: Evaluate WCM System End-To-End Performance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Boston Scientific
state: Minnesota
Study officials:
affiliation: Senior R&D Fellow
name: Dave Perschbacher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018225: Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Nocturia
Lead sponsor: Cognitive Research Corporation
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2009-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia.


Eligibility criteria: Inclusion Criteria:

* Subject must be aged 21-70, inclusive.
* Subject mush have given written, personally signed and dated informed consent.
* Subject must be diagnosed with overactive bladder.
* Subject must have a nocturia frequency of greater than or equal to 3 episodes a night.
* Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements.
* Subject understands and is able, will a nd and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

* Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
* The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components).
* The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions.
* Subject is taking another drug which is considered to have significant anticholinergic activity.
* Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs.
* Subject has moderate to severe obstructive sleep apnea (Apnea/Hypopnea Index ≥ 15)
* Subject has a medical condition other than OAB that is the most likely cause of the subject's nocturia (e.g., primary sleep disorder, polydipsia, polyuria).
* Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
* The female subject is pregnant or lactating.
* Subjects with a urine drug screen positive for stimulants, barbiturates, hallucinogens, opiates, cocaine, cannabis, or amphetamines

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04493125: Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy
Official title: The Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy: Prospective, Double Blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Cancer
Keywords: Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: "Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. In a case-control study of patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas passing and defecation time.

Recently, a study reported that mosapride citrate acts on the α7nACh receptor and, consequently, suppresses the inflammatory response of macrophages, thereby suppressing the mechanism that induces paralysis after surgery.

To date, this study is intended to analyze whether mosapride citrate significantly affects the improvement of bowel movement after surgery after gastrectomy."


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with gastric cancer pathologically before surgery
2. Patients who underwent surgical resection (R0 resection)
3. Patients with an ASA score of 3 or less

Exclusion Criteria:

1. Patients over 80 years old
2. When there are multiple or peritoneal metastases
3. Intestinal obstruction before surgery
4. When chemotherapy was performed before surgery
5. When cancer other than stomach cancer is diagnosed
6. If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy
7. In case of liver failure or kidney failure
8. When it is judged that uncontrolled diabetes may affect intestinal function

Primary outcomes:
measure: The number of radiopaque markers transferred to the large intestine 3 days after surgery
timeFrame: 3 Days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT01375725: Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
Official title: Mobius PT-INR Accuracy Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clotting Disorders
Lead sponsor: Universal Biosensors Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects currently receiving coumadin (warfarin) treatment

Brief summary: The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.


Eligibility criteria: Inclusion Criteria:

* Are currently taking coumadin (warfarin)
* Are aged 18 years or older
* Able and willing to provide informed consent
* Can understand (read and write) English
* Required to provide a capillary sample as part of their routine medical check

Exclusion Criteria:

* Previously participated in this study

Primary outcomes:
measure: PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
timeFrame: Five days to collect data and up to two weeks to generate correlation graph
Secondary outcomes:
Other outcomes:
Locations:
city: Batesville
country: United States
facility: White River Diagnostic Clinic
state: Arkansas
Study officials:
affiliation: Harding University
name: Richard Ward, Pharm.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05301725: Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy Against Helicobacter Pylori
Official title: Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy as First-line Treatment Against Helicobacter Pylori
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori; Eradication Rate
Keywords: Helicobacter pylori,eradication therapy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: helicobacter infection

Brief summary: Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.

Detailed description: This study retrospectively enrolled participants with H. pylori infection who received bismuth quadruple regimen containing clarithromycin. The basic information, treatment results, adverse reactions and compliance of the patients were collected. According to the type of acid inhibitors, participants were divided into traditional PPI group and P-CAB group. Traditional PPI group which were divided into lansoprazole group and esomeprazole group. The eradication rate, safety, compliance of H. pylori in different treatment regimens was evaluated. Multivariate analysis was performed to identify predictors of eradication failure.

Eligibility criteria: Inclusion Criteria:

* Participants aged 18-75 years with persistent H. pylori infection.
* Participants received clarithromycin-based bismuth-containing quadruple therapy.

Exclusion Criteria:

* Patients received rescue therapy
* Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks
* Patients with gastorectomy
* Currently pregnant or lactating or other conditions unable to receive therapy
* Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk
* Severe neurologic or psychiatric disorders
* Information incomplete

Primary outcomes:
measure: Rate of eradication success
timeFrame: 1 month
measure: Prevalence of adverse events
timeFrame: 1 month
measure: Number of participants with good compliance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
References:
Clinical trial NCT06601725: Clusterin Level and Polycystic Ovary Syndrome
Official title: Clusterin Level Determination and Its Association With Metabolic Syndrome in Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Ovulation Disorder
Keywords: clusterin
metabolic syndrome
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 118 women who were diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, as well as 62 healthy women of the same age without any cardiovascular risk factors. Patients diagnosed with PCOS were classified into four phenotypes: A, B, C, and D. Phenotype A was characterized by metabolic syndrome, phenotype B was characterized by the absence of metabolic syndrome, phenotype C was characterized by hyperandrogenism, and phenotype D was characterized by the absence of hyperandrogenism.

Brief summary: Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.

Detailed description: The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.

Eligibility criteria: Inclusion Criteria:

* Women aged between 18 and 45,
* natural bilateral ovaries and no functional cysts on transvaginal ultrasound.

Exclusion Criteria:

* who have hyperandrogenism/hyperandrogenemia
* who have non-classical congenital adrenal hyperplasia (17 OHP value \>2 nmol/L)
* who have thyroid disease (TSH \>5 mlU/L),
* women with hyperprolactinemia (Prolactin\>30 mlU/mL)
* patients taking hormonal drugs or ovulation induction agents.

Primary outcomes:
measure: CLusterin level
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı Yenigül
Study officials:
References:
Clinical trial NCT00378625: Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia
Official title: Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria,Falciparum
Malaria
Antimalarials
Lead sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2006-09-20
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of:

* Efficacy
* Tolerability
* Time of fever clearance
* Time of parasite clearance
* Proportion of gametocyte carriers


Eligibility criteria: Inclusion Criteria:

1. pure P. falciparum infection
2. parasitaemia \>500 and \<50,000 asexual parasites/μL (subsequently the lower limit was modified to \>250 asexual parasites/μL)
3. age between 1 and 65 years old
4. availability to return for follow-up

Exclusion Criteria:

1. Pregnancy
2. history of allergy to the study drugs
3. history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
4. have a medical history of untreated hypertension or chronic heart, kidney or liver disease
5. present any danger signs of severe malaria.

Primary outcomes:
measure: treatment failures
measure: adverse events
measure: gametocyte carriage
Secondary outcomes:
Other outcomes:
Locations:
city: Quibdo
country: Colombia
facility: Hospital Ismael Roldan and Centro de Salud San Vicente
state: Choco
Study officials:
affiliation: Centro Internacional de Entrenamiento e Investigaciones Médicas
name: Lyda Osorio, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088225: Myopia Preventing With Distance-image Screen
Official title: Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Keywords: Myopia; children
Lead sponsor: Beijing Airdoc Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Paired testing those ocular parameters before and after 12-month usage of distance-image screen
Primary purpose: PREVENTION

Brief summary: This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.

Detailed description: This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing.

All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.

Eligibility criteria: Inclusion Criteria:

* (1) Must be 6\~12 years old;
* (2) Must be best corrected visual acuity \< logMAR: 0.1;
* (3) Spherical Equivalence (SE) must be -1.00\~ + 6.00 Diopter (D),
* (4) Spherical Equivalence (SE) must have changed \> 1.25 Diopter (D) in the recent 2 years;
* (5) Must be astigmatism \<1.75 Diopter (D);
* (6) Must be anisometropia \<1.75 Diopter(D).

Exclusion Criteria:

* (1) Strabismus disease;
* (2) Amblyopia disease;
* (3) Cataract disease;
* (4) Glaucoma disease;
* (5) Severe dry eye disease;
* (6) Cannot use distance-image screen for 12 month;
* (7) Other severe diseases that would effect the use of distance-image screen.

Primary outcomes:
measure: Changes of ocular axial length (mm)
timeFrame: 12-month
measure: Changes of refractive error (D)
timeFrame: 12-month
Secondary outcomes:
measure: Changes of center macular thickness (um)
timeFrame: 12-month
measure: Changes of subretina choroidal thickness (um)
timeFrame: at 12-month
measure: Changes of other regions choroidal thickness (um)
timeFrame: 12-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Airdoc MPC Opthalmology Clinics
state: Beijing
Study officials:
References:
Clinical trial NCT03415425: Optimizing the Influenza Clinical Decision Support Tool
Official title: Optimizing the Influenza Clinical Decision Support Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Decision Support
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 25881
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study aims to examine several iterations of the Influenza Best Practice Alert at NYU Langone Health. The goal is to increase ordering of the influenza vaccine through the alert.


Eligibility criteria: Inclusion Criteria:

* All NYU Langone Health inpatients eligible for the Influenza clinical decision support tool

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Alert Cancelation Rate
timeFrame: 2 months.
Secondary outcomes:
measure: Vaccination Rate at Discharge
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leora Horwitz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Austrian J, Mendoza F, Szerencsy A, Fenelon L, Horwitz LI, Jones S, Kuznetsova M, Mann DM. Applying A/B Testing to Clinical Decision Support: Rapid Randomized Controlled Trials. J Med Internet Res. 2021 Apr 9;23(4):e16651. doi: 10.2196/16651.