louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06205693: Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy
Official title: Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula Pancreatic
Keywords: Fistula
postoperative pancreatic fistula
pancreatoduodenectomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, blinded clinical superiority trial
Primary purpose: PREVENTION

Brief summary: The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.

The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing a pancreatoduodenectomy
2. Patients aged 18 or above
3. Patients who have given an informed consent

Exclusion Criteria:

1. Patients who do not or cannot give an informed consent.
2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
3. Patients undergoing active immunosuppressive therapy.

Primary outcomes:
measure: POPF
timeFrame: 30 days
measure: Number of participants with a Biliary fistula
timeFrame: 30 days
Secondary outcomes:
measure: Complications to stent placement
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days postoperative
measure: Mortality
timeFrame: 30 days and 90 days
measure: LOS
timeFrame: Length in days, from surgery until discharge ( up to 200 days from surgery)
measure: Quality of Life according to VR12 Quality of Life Score
timeFrame: 30 days post surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capitol
Study officials:
References:
Clinical trial NCT04949893: Causes of Chronic Pruritus
Official title: Causes of Chronic Pruritus: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pruritus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 200
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: Inclusion of all patients with chronic pruritus followed in our dermatology department between 2008 and 2018

Brief summary: The aim of this study is to include all patients followed between 2008 and 2018 in order to analyze the etiologie of the chronic pruritus


Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* In patient in a day hospital or longer hospitalization in the dermatology department
* With chronic pruritus which means pruritus longer than 6 weeks without skin lesions specific to pruritic dermatitis.

Exclusion Criteria:

* Itchy dermatose
* Refusal to particpate

Primary outcomes:
measure: Causes of chronic pruritus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT05112211: Multi-model Image of Doxycycline in TAO
Official title: A Multi-model Image to Evaluate the Efficacy of Doxycycline in Thyroid Associated Ophthalmopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Associated Ophthalmopathy
Keywords: Doxycycline
Thyroid Associated Ophthalmopathy
Extraorbital muscle
Orbit fat volume
Multi-modal image
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients diagnosed by Thyroid-Associated Ophthalmopahty
Primary purpose: SCREENING

Brief summary: This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal image.

Detailed description: Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. Different degrees of exophthalmos, eyelid aperture, lid retraction and lid lag are common symptoms apprearing in TAO. The improvement of exophthalmos is usually measured with Hertel instrument and the change of eyelid is measured with millimeter ruler. All these measurements are subjective, low reliable and less accurate.

TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. But still a progression and reoccurrence can be a big challenge for ophthalmologists. This is a perspective cohort study to evaluate the efficacy of doxycycline in TAO by multi-model image.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 18-70 years old
* Diagnosed with TAO

Exclusion Criteria:

* Sight-threatening TAO with dysthyroid optic neuropathy
* Allergy of tetracycline
* Have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination)

Primary outcomes:
measure: change of extraocular muscle volume and orbital fat volume by MRI
timeFrame: at month 6
Secondary outcomes:
measure: change of exophthalmos
timeFrame: at month 6
measure: change of Quality of Life
timeFrame: at month 6
measure: change of eyelid aperture, lid retraction and lid lag
timeFrame: at month 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Dan Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232011: Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis
Official title: A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, ASM981, pimecrolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in Japanese adult patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility criteria: Inclusion Criteria:

* Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
* Patients who had given written informed consent to participation in this study

Exclusion Criteria:

* Patients who failed in treatment compliance in the core study
* Patients who had a major violation of the protocol in the core study

Primary outcomes:
measure: Safety assessed by adverse events (AEs)
Secondary outcomes:
measure: Number of disease flares during 26 weeks of treatment
Other outcomes:
Locations:
city: Various Cities
country: Japan
facility: This study is not being conducted in the United States
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References:
Clinical trial NCT00846911: AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
Official title: AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis, Chronic
Keywords: Acute Exacerbation of Chronic Bronchitis (AECB) patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 2672
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events.

This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.


Eligibility criteria: Inclusion Criteria:

* Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic Bronchitis (AECB) and decision taken by the investigator to treat with Avelox.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.

Primary outcomes:
measure: Time until improvement of acute exacerbation
timeFrame: End of study
Secondary outcomes:
measure: Time until cure of acute exacerbation
timeFrame: End of study
measure: Severity of AECB according to Antonisen criteria
timeFrame: Baseline
measure: Impact of AECB on daily life activities
timeFrame: Baseline
measure: Safety of Avelox under daily life treatment conditions
timeFrame: Throughout treatment
Other outcomes:
Locations:
city: Many Locations
country: Albania
city: Many Locations
country: Bosnia and Herzegovina
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Macedonia, The Former Yugoslav Republic of
city: Many Locations
country: Moldova, Republic of
city: Many Locations
country: Russian Federation
city: Many Locations
country: Slovakia
city: Many Locations
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Chuchalin A, Zakharova M, Dokic D, Tokic M, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI). BMC Pulm Med. 2013 Jan 23;13:5. doi: 10.1186/1471-2466-13-5.
Clinical trial NCT03016611: Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
STEMI
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.


Eligibility criteria: Inclusion Criteria:

1. Patients presenting with STEMI
2. Informed, written consent

Exclusion Criteria:

1. Age \< 18 years or Age \> 75 years
2. Active bleeding; bleeding diathesis; coagulopathy
3. Increased risk of bradycardic events
4. History of gastrointestinal or genitourinary bleeding \<2 months
5. Major surgery in the last 6 weeks
6. History of intracranial bleeding or structural abnormalities
7. Suspected aortic dissection
8. Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy \<1 year)
9. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
10. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
11. Known relevant hematological deviations: Hb \<10 g/dl, PLT\<100x10\^9/l
12. Use of coumadin derivatives within the last 7 days
13. Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
14. Known severe liver disease, severe renal failure
15. Known allergy to the study medications
16. Pregnancy
17. Human immunodeficiency virus treatment
18. The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days).
19. If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.

Primary outcomes:
measure: Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after Ticagrelor/Prasugrel LD
timeFrame: 1 hour
Secondary outcomes:
measure: The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after Ticagrelor/Prasugrel LD
timeFrame: 4-6 hours
measure: Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
timeFrame: 30 days
measure: Occurrence of dyspnea and/or symptomatic bradycardia
timeFrame: 30 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical center
Study officials:
References:
Clinical trial NCT05576311: Codesign of an Optical Device to Measure Urine Flow and Volume
Official title: Conducting Focus Groups With Patients and Healthcare Practitioners to Inform the Development of a Sensor Which Measures Urine Flow, Volume and Voiding Patterns, in Order to Diagnose Pathologies of the Urinary System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence
Urinary Retention
Urinary Tract Infections
Overactive Bladder
Benign Prostatic Hyperplasia
Underactive Bladder
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: South Tees Hospitals NHS Foundation Trust
First posted: 2022-10-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients with urinary symptoms referred to Consultant Urological Surgeon Ms Mehwash Nadeem at the James Cook Hospital, Middlesbrough or the Friarage Hospital, Northallerton.

Brief summary: The study is seeking to understand the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed. This information will be used in the design and evaluation of a device, being developed in parallel, that assesses changes to the volume and flow of urine in order to determine changes in bladder function.

In order to ensure development is optimal, the principal research objective is therefore to understand the needs of patients and healthcare practitioners (ranging from care home staff and GPs in primary care, to urologists in tertiary referral centres).


Eligibility criteria: Inclusion criteria The participant is willing and able to give informed consent for participation in the study.

Aged 18 years or above. Male or Female.

Exclusion criteria The participant is unwilling or unable to give informed consent for participation in the study.

Aged 17 years or younger.

Primary outcomes:
measure: Understanding the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed.
timeFrame: November 2022 - February 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04938011: A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
Official title: A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 900
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: This is a single-center, prospective, randomized controlled study. Patients with single blastocyst transfer in the freeze-thaw cycle, aged from 20 to 38 years, with less than three transfers, and with HRT-cycle single D6 blastocyst transfer in the current cycle were enrolled as the study participants. They were randomized into two groups using an Excel table, and the efficacy was evaluated in a blinded manner by a third party who was unaware of the grouping; the data summary phase was performed by blinded statistical analysis with triple separation of the investigator, operator, and statistician.


Eligibility criteria: Inclusion Criteria:

1. Aged 20 to 38 years.
2. Less than three transfers.
3. Undergoing HRT freeze-thaw cycle single blastocyst transfer in the current cycle.
4. Having consented to participate in this study and signed the informed consent form.

Exclusion Criteria:

1. Chromosomal abnormality in either the patient or their partner
2. Contraindications to hormone replacement therapy.
3. Patients with intramural myoma affecting the morphology of the uterine cavity, severe adenomyosis, endometriosis, congenital uterine anomalies, endometrial tuberculosis, intrauterine adhesion and other diseases significantly affecting embryonic implantation.
4. Currently participating in another clinical study.

Primary outcomes:
measure: Embryo implantation rate
timeFrame: 30 days after embryo transplantation
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 NCT06834711: Chlorhexidine Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis
Official title: Chlorhexidin Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis on Postoperative Pain and Periapical Tissue Healing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Apical Periodontitis
Keywords: chronic apical periodontitis
postoperative pain
N-asetil sistemin
chlorhexidin
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical study was to evaluate the effect of using different irrigation solutions in the final irrigation of root canal treatment procedures on the intensity of postoperative pain and periapical tissue healing in patients presenting with mandibular molars with chronic apical periodontitis. The main question it aims to answer is:

- Does controlled irrigation with chlorhexidin and N-asetil sistein in root canal treatment reduce the severity of postoperative pain? In the chlorhexidin group, unlike the control group, each root canal was irrigated with 3 mL %2 chlorhexidin solution in the final irrigation.

In the N-asetil sistein group, unlike the control group, each root canal was irrigated with 3 mL 200 mg/ml N-asetil sistein solution in the final irrigation.


Eligibility criteria: Inclusion Criteria:

* Mandibular permanent molars with chronic apical periodontitis
* Teeth with periapical index (PAI) score greater than 2
* Teeth with periodontal pocket depth less than 3 mm
* Patients without systemic disease (ASA 1-2)

Exclusion Criteria:

* Patients who have used analgesic, anti-inflammatory or opioid drugs in the last 7 days or antibiotics in the last 3 months
* Patients who report pregnancy, lactation or psychiatric disorders
* Teeth with a history of root canal treatment, sinus tract or abscess, and teeth planned for prosthetic restoration

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıçam
Study officials:
References:
citation: Corazza BJM, Martinho FC, Khoury RD, Toia CC, Orozco EIF, Prado RF, Machado FP, Valera MC. Clinical influence of calcium hydroxide and N-acetylcysteine on the levels of resolvins E1 and D2 in apical periodontitis. Int Endod J. 2021 Jan;54(1):61-73. doi: 10.1111/iej.13403. Epub 2020 Oct 3.
citation: Comparative evaluation of N-acetylcysteine and chlorhexidine as final irrigation on the push-out bond strength of different sealers: An in vitro study