louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01863797: Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nulliparous Women With Prolonged Latent Phase
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 138
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to compare early induction versus expectant management regarding outcome and experience of delivery in nulliparous women with a prolonged latent phase.


Eligibility criteria: Inclusion Criteria:

* generally healthy nulliparous women and normal pregnancies (in vitro-fertilisation included)
* with a singleton fetus in cephalic presentation,
* gestational age between 37+0 and 41+6,
* continuous contractions exceeding 18 hours impeding rest (women's report),
* a cervical dilation of less than four centimetres and intact membranes. Gestational age was confirmed by ultrasound in the first trimester.

Women had to be able to read, understand and speak Swedish.

Primary outcomes:
measure: The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Maternal outcome measure included experience of delivery
timeFrame: Experience of delivery was assessed two days after delivery
Other outcomes:
measure: Maternal outcome measures included duration of labour, labour analgesia, intrapartum exogenous oxytocin stimulation, partum haemorrhage, number of sphincter tears.
timeFrame: Duration of labour, labour analgesia, intrapartum exogenous oxytocin stimulation were measured from cervical dilatation of 4 cm until delivery. Post partum hemorrhage was measured two hours after delivery. Sphincter tear measure directly after delivery.
measure: Neonatal outcomes; birth presentation, Apgar score below 7 and cord artery metabolic acidosis, admission to neonatal intensive care (NICU), birth weight and child's head circumference
timeFrame: Neonatal outcomes were measured from delivery and until two days after delivery.
Locations:
city: Stockholm
country: Sweden
facility: Förlossningen, Danderyd Hospital
Study officials:
References:
Clinical trial NCT06494397: Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Official title: Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Schizophrenia
Bipolar I Disorder
Keywords: Iloperidone
VHX-896
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.


Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 to 65 years of age (inclusive)
* Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type, according to the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-5-TR)
* Patients must be symptomatically stable and on a stable treatment with an oral atypical antipsychotic at an adequate dose (3 months prior to enrollment) and not suffer from acute increase of their psychosis or be hospitalized within the past 2 months

Exclusion Criteria:

* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Cytochrome P450 2D6 (CYP2D6) poor metabolizers and use of prescription medication or OTC medication that strongly inhibits CYP2D6 or CYP3A4 or induces CYP3A4 within 5 half-lives of baseline

Primary outcomes:
measure: Bioequivalence between VHX-896 tablets relative to iloperidone tablets
timeFrame: 12 hours
Secondary outcomes:
measure: Assessment of safety and tolerability of VHX-896 and iloperidone
timeFrame: 24 days
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Vanda Investigational Site
state: California
city: Gaithersburg
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Marlton
country: United States
facility: Vanda Investigational Site
state: New Jersey
Study officials:
References:
Clinical trial NCT04830397: Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
Official title: A Randomized Active-controlled Multi-site Double-masked Study to Evaluate the Safety and Tolerability of 3 Concentrations of QLS-101 Versus Timolol Maleate Preservative Free (PF) 0.5% Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: elevated intraocular pressure
Lead sponsor: Qlaris Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 84
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: Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

Detailed description: Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension

Eligibility criteria: Inclusion Criteria:

1. Visual acuity +1.0 logMAR or better
2. Willing to give informed consent
3. Ability to washout from current intraocular pressure lowering medications -

Exclusion Criteria:

1. Severe glaucomatous damage
2. Previous glaucoma intraocular or laser surgery
3. Refractive surgery
4. Ocular infection or inflammation

Primary outcomes:
measure: Ocular safety
timeFrame: 100 days
Secondary outcomes:
measure: Ocular hypotensive efficacy
timeFrame: 28 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Dixon Eye Care
state: Georgia
Study officials:
References:
Clinical trial NCT01127997: The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic Patients
Official title: The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 diabetic patients

Brief summary: Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not clear whether it is also observed in type 2 diabetic patients. This study aims to define whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for the mechanism.


Eligibility criteria: Inclusion Criteria:

* age 35-70
* HbA1c 6-8%
* DM duration less than 5 yrs

Exclusion Criteria:

* type 1 DM, secondary DM, gestational DM
* patients using insulin, TZDs
* patients using corticosteroid, herb medication or other medications affecting glucose tolerance
* renal dysfunction (Cr \> 1.5mg/dL)
* hepatic dysfunction (LFT \> x 3UNL)
* anemia (Hg \< 10g/dL)
* ischemic heart disease, congestive heart failure
* severe diabetic complication (CRF, CVA, PDR, gastroparesis)
* infectious disease
* malignancy
* pregnant women

Primary outcomes:
measure: Area under the curve of plasma glucose after meal
timeFrame: 3 months
Secondary outcomes:
measure: the mechanism of second-meal phenomenon
timeFrame: 3 months
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's hospital
state: Kyounggi-do
Study officials:
References:
citation: Jovanovic A, Leverton E, Solanky B, Ravikumar B, Snaar JE, Morris PG, Taylor R. The second-meal phenomenon is associated with enhanced muscle glycogen storage in humans. Clin Sci (Lond). 2009 Jul 2;117(3):119-27. doi: 10.1042/CS20080542.
citation: Bonuccelli S, Muscelli E, Gastaldelli A, Barsotti E, Astiarraga BD, Holst JJ, Mari A, Ferrannini E. Improved tolerance to sequential glucose loading (Staub-Traugott effect): size and mechanisms. Am J Physiol Endocrinol Metab. 2009 Aug;297(2):E532-7. doi: 10.1152/ajpendo.00127.2009. Epub 2009 Jun 16.
citation: Jovanovic A, Gerrard J, Taylor R. The second-meal phenomenon in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1199-201. doi: 10.2337/dc08-2196. Epub 2009 Apr 14.
citation: Lee SH, Tura A, Mari A, Ko SH, Kwon HS, Song KH, Yoon KH, Lee KW, Ahn YB. Potentiation of the early-phase insulin response by a prior meal contributes to the second-meal phenomenon in type 2 diabetes. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E984-90. doi: 10.1152/ajpendo.00244.2011. Epub 2011 Aug 9.
Clinical trial NCT05896397: European Aortic Data Collection Project
Official title: European Aortic Data Collection Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complex Abdominal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Aortic Arch Aneurysm
Chronic Aortic Dissection
Keywords: Complex aortic repair
Aortic aneurysm
Aortic dissection
Fenestrated/branched endograft
Custom-made endovascular graft
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 600
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 receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.

Brief summary: The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices.

The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.


Eligibility criteria: Inclusion Criteria:

1. Patients who will be treated with a Cook CMD

Exclusion Criteria:

1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or
2. Patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.

Primary outcomes:
measure: Rate of treatment success
timeFrame: 12 months
measure: Rate of safety outcomes
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Le Plessis-Robinson
country: France
facility: Hopital Marie Lannelongue
city: Lille
country: France
facility: CHU de Lille
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf
city: Munich
country: Germany
facility: LMU Klinikum Munich
city: Münster
country: Germany
facility: St. Franzikus-Hospital Munster
city: Nürnberg
country: Germany
facility: Klinnikum Nurnberg
city: Bologna
country: Italy
facility: PoliclinicoS Orsola Malpighi
city: Genova
country: Italy
facility: Ospedal Policlinico San Martino-HSM
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital Malmo
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: Hopital Marie Lannelongue
name: Stephan Haulon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00539097: Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Burn
Reconstructive Surgical Procedure
Keywords: pediatrics
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hope to learn if taking a nutrition drink for a short time after surgery for an elective reconstructive burn injury improves donor site healing, muscle mass and scar maturation time (the point at which the redness, height and firmness of the wound has faded, flattened and softened, and no longer changes in appearance).


Eligibility criteria: Inclusion Criteria:

* At least one year post-acute burn injury
* Admitted for surgery whereby split thickness donor site created
* Received initial acute treatment at Shriner's Hospital in Cincinnati

Exclusion Criteria:

* Less than 6years of age
* Less than one year from acute burn injury
* Split thickness donor site/autograft not anticipated
* Initial treatment not at Shriners Hospital in Cincinnati

Primary outcomes:
measure: donor site healing time
timeFrame: 3weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
affiliation: Shriners Hospital for Children, Cincinnati, Ohio
name: Theresa M Mayes, RD,LD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05281497: Hemodialysis Health Management Model
Official title: Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Nutritional Wasting
Keywords: Hemodialysis
Wearable device
Health management platform
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group and control group
Primary purpose: TREATMENT

Brief summary: Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.

Detailed description: Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. If patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care.

Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.

Material and Methods: The investigators plan to recruit 30 CKD patients as trial subjects for intervention. The intervention included wearable devices and health management platform for 24 weeks. Patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators compare physical and laboratory examinations before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* age 20 years and older
* diagnosis of ESRD receiving maintenance HD for more than 3 months

Exclusion Criteria:

* inability to use a smartphone
* impaired walking capacity
* having a psychiatric disorder
* any hospitalization during the previous 3 months.
* has been changing dialysis modality or receiving renal transplantation

Primary outcomes:
measure: Change of sit-to-stand-10 (STS-10)
timeFrame: baseline, week 4, week 8, week 12, week 16 and week 24
measure: Change of sit-to-stand-60 (STS-60)
timeFrame: baseline, week 4, week 8, week 12, week 16 and week 24
measure: Change of 6-minute walking distance (6MWT)
timeFrame: baseline, week 4, week 8, week 12, week 16 and week 24
measure: Change of hand grip strength
timeFrame: baseline, week 4, week 8, week 12, week 16 and week 24
Secondary outcomes:
measure: Change of KDQOL-SF
timeFrame: baseline, week 4, week 8, week 12, week 16 and week 24
measure: Change of subjective global assessment (SGA)
timeFrame: baseline, week 4, week 8, week 12, week 16 and week 24
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wen-Yi Li
Study officials:
affiliation: National Taiwan University Hospital
name: Wen-Yi Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT04390997: Determination of the Levels of Lipocalin-2 and Semaphorin3A
Official title: Determination of the Levels of Lipocalin-2 and Semaphorin3A in Gingival Crevicular Fluid in Subjects With Different Periodontal Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Periodontitis
Periodontal Diseases
Keywords: Periodontal Disease, Non-surgical Periodontal Treatment, GCF
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. At the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.

Detailed description: In our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment.

Possible significant differences may illuminate the future work with Lipocalin-2 and Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.

Eligibility criteria: Inclusion Criteria:

* Being systemically healthy
* Having at least 20 teeth in the dentition, excluding third molars
* Not using alcohol nor smoking
* Not using medications
* Not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months
* Not being in the lactation period nor pregnancy

Exclusion Criteria:

* Having any oral or systemic diseases
* Using alcohol or smoking
* Using medications
* Taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months
* Being in the lactation period or pregnancy
* Being treated with periodontal treatment in the last six months

Primary outcomes:
measure: The level of Lipocalin-2
timeFrame: 18 months
measure: The level of Semaphorin 3A
timeFrame: 18 months
Secondary outcomes:
measure: Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A
timeFrame: 18 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University, Faculty of Dentistry
state: Cigli
Study officials:
References:
Clinical trial NCT04511897: Efficacy and Safety of An'Ningpai Expectorant in Non-CF Bronchiectasis
Official title: Efficacy and Safety of An'Ningpai Enteric Soft Capsuleson in Stable Non-CF Bronchiectasis With Hypersecretion: a Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchiectasis Adult
Keywords: Brochiectasis Adult
Hypersecretion
Exacerbation
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 200
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 objective of this study was to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsuleson (300 mg, three times daily, 12 months) might reduce the incidence of exacerbations and improve the quality of life in patients with Non-CF bronchiectasis.

Detailed description: Mucus hypersecretion plays an essential role in bronchiectasis. It has been deduced that reducing the production of mucus or improving the clearance of sputum in the airway is the key to break down this "vicious cycle" and enhance the therapeutic efficacy for bronchiectasis.

The investgators aimed to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsules (300 mg, three times daily) might reduce the rate of exacerbations and improve the quality of life in patients with bronchiectasis.

Eligibility criteria: Inclusion Criteria:

1) subjects older than 18 ; 2)a diagnosis of bronchiectasis was according to the 2010 British Thoracic Society guidelines; 3) with hypersecretion ：high viscous sputum symptoms (sputum traits score 2-3 points) ;4) patients had least two exacerbations in the past year and were in a state for at least 4 weeks prior to randomization

Exclusion Criteria:

1) cystic fibrosis or other etiologies (such as immunodeficiency, allergic bronchopulmonary aspergillosis, traction bronchiectasis caused by emphysema, advanced pulmonary fibrosis, etc.); 2)primary diagnosis of COPD or asthma; 3)a history of severe cardiovascular disease; 4)comorbidity with liver disease, kidney disease, malignant tumor, gastric ulcer, or intestinal malabsorption; 5)a known allergy to Eucalyptol , Limonene and Pinene Enteric Soft Capsules; 6)pregnancy or lactation (for women);7)a history of prior macrolide use of more than 1 week; 8)and poor compliance

Primary outcomes:
measure: Numbers of acute exacerbation
timeFrame: one year
Secondary outcomes:
measure: The time to first exacerbation
timeFrame: one year
measure: The volume of 24h sputum
timeFrame: Six months
measure: Leicester Cough Questionnaire
timeFrame: Six months
measure: Questionnaire of life-Bronchiectasis
timeFrame: Six months
measure: Incidence of diarrhea
timeFrame: Six months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-fu Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: