louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03899818: Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
Official title: Impiego Del Pallone Medicato Per il Trattamento di Piccoli Vasi Coronarici in Confronto Con Stent Medicato - Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: small vessels
drug coated balloon
Lead sponsor: Fatebenefratelli and Ophthalmic Hospital
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 240
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: This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina


Eligibility criteria: Inclusion Criteria

1. Age \>18 years.
2. Stable or unstable coronary artery disease.
3. Native coronary artery lesion in vessel with diameter \<2.75 mm.
4. Clinical indication to percutaneous coronary intervention (PCI).

Exclusion criteria

1. Enrolment in another study with any investigational drug or device.
2. Acute or recent (≤48 hours) myocardial infarction.
3. Creatinine clearance \<50 ml/min.
4. Left ventricle ejection fraction \<30%.
5. Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
6. Heavily calcified and severely tortuous lesions.

Primary outcomes:
measure: Verify the non-inferiority of DCB
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of Participants with changes of vessels lumen
timeFrame: up to 12 months
measure: Concentration in blood chemistry
timeFrame: up to 6 months
measure: Number of Participants with adverse events
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2840-2849. doi: 10.1016/j.jcin.2020.08.035. Epub 2020 Nov 25.
Clinical trial NCT05175118: Minimally Invasive Fixation for Distal Radius Fractures
Official title: Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments

Detailed description: Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

Eligibility criteria: Inclusion Criteria:

1. patients with unstable distal radial fracture
2. skeletally mature Patients.
3. Acute fractures within one weeks of injury

Exclusion Criteria:

1. contaminated open fractures.
2. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture

Primary outcomes:
measure: Fracture healing
timeFrame: 6 minths
measure: Wrist function
timeFrame: One year
Secondary outcomes:
measure: Fracture compilations
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ab Ma Ghozaly
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liverneaux PA. The minimally invasive approach for distal radius fractures and malunions. J Hand Surg Eur Vol. 2018 Feb;43(2):121-130. doi: 10.1177/1753193417745259. Epub 2017 Dec 12.
citation: Chmielnicki M, Prokop A. [New minimally invasive approach for palmar plating in distal radius fractures]. Z Orthop Unfall. 2015 Feb;153(1):25-8. doi: 10.1055/s-0034-1383103. Epub 2015 Feb 27. German.
citation: Igeta Y, Vernet P, Facca S, Naroura I, Hidalgo Diaz JJ, Diaz JJH, Liverneaux PA. The minimally invasive flexor carpi radialis approach: a new perspective for distal radius fractures. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1515-1522. doi: 10.1007/s00590-018-2124-z. Epub 2018 Jan 24.
citation: Slutsky DJ. Outcomes assessment in wrist surgery. J Wrist Surg. 2013 Feb;2(1):1-4. doi: 10.1055/s-0033-1333892. No abstract available.
Clinical trial NCT03069118: 90-Day Online Substance Use Program
Official title: Effectiveness of a Remote Behavioral Intervention and Coaching Support for Risky Substance Users in a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addictive Behavior
Alcohol Use Disorder
Alcohol Abuse
Drug Abuse
Drug Use Disorders
Keywords: Telemedicine
Online Treatment
Digital Intervention
Lead sponsor: Workit Health
Sponsor class: INDUSTRY
First posted: 2017-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals indicating risky substance use are randomly assigned either to a three-month online intervention on the Workit Health platform or a waitlist/treatment as usual. Those randomized to treatment will report reduced consumption of alcohol and other drugs and higher quality of life at study conclusion.


Eligibility criteria: Inclusion Criteria:

* Subjects of this research are adults who self-identify as wanting to change their relationship to alcohol or drugs, who report currently using alcohol or drugs, or having recently stopped, who have access to an internet-enabled device, who are not currently suffering from untreated acute medical or psychiatric conditions, who anticipate being able to access the intervention over a six-month period, and who are able to freely consent to participate by themselves.

Exclusion Criteria:

* Because the intervention is written for an adult audience, as well as the logistical challenges of having private access to an internet enabled device, this research is limited to participants over the age of 18.

Primary outcomes:
measure: ASSIST
timeFrame: 90-day
measure: WHOQOL-BREF
timeFrame: 90-day
Secondary outcomes:
measure: Net Promoter Score
timeFrame: 90-day
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Workit Health
state: Michigan
Study officials:
affiliation: Workit Health
name: Lisa McLaughlin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517018: UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation
Official title: COMPARISON OF SINGLE, DOUBLE LAYER AND PURSE STRING TECHNIQUE (TURAN TECHNIQUE) STUR TYPES IN TERMS OF THE FORMATION OF UTERINE NICH FOR CLOSING THE UTERUS DURING CESERIAN SECTION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterus; Scar
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-26
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need to have a cesarean section will be included in the study.participants will be randomly divided into 3 groups according to the cesarean section technique.During the cesarean section, the uterus will be closed using different techniques for each of the 3 groups.6 weeks after the operation, they will be called for control and evaluated in terms of niche formation. and rezidue myometrial tissue

Brief summary: We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)

Detailed description: It is thought that the formation of the uterine niche may be mostly due to the surgical technique.We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique).

Eligibility criteria: Inclusion Criteria:

* have a cesarean section necessity
* be over 18 years old
* being younger than 40

Exclusion Criteria:

* emergency cesarean section
* Being under 37 weeks pregnant
* multiple pregnancies
* having had uterine surgery
* uterine malformations

Primary outcomes:
measure: the formation of a uterine niche
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
state: Gaziosmanpaşa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: elif yıldız
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00369018: A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
Official title: Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Dysplasia
Keywords: photodynamic therapy
methyl aminolevulinate
hexaminolevulinate
dose-finding
cervical dysplasia
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

Detailed description: Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.

This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.

Eligibility criteria: Inclusion Criteria:

* Positive histology of CIN 1-3

Exclusion Criteria:

* Patients with endocervical lesions
* Patients with AGUS
* Patients with invasive disease
* Patients with porphyria
* Patients sensitive to MAL and HAL

Primary outcomes:
measure: Lesion eradication
timeFrame: 6 months
Secondary outcomes:
measure: Eradication of lesion and HPV
timeFrame: 6 and 12 months
measure: Safety assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
city: Oslo
country: Norway
facility: Ullevål University Hospital, Department of Obstetrics and Gynecology
Study officials:
affiliation: Hannover Medical School
name: Peter Hillemanns, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06944418: The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases
Official title: The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases Based on Flow Cytometry Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophil Subtype
Eosinophilic Pulmonary Diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients diagnosed with EPD who meet the inclusion criteria above.

Brief summary: The study subjects of this research are patients with eosinophil-associated pulmonary diseases, including eosinophilic granulomatosis with polyangiitis, idiopathic hypereosinophilic syndrome, idiopathic acute eosinophilic pneumonia, idiopathic chronic eosinophilic pneumonia, and primary simple pulmonary eosinophilia. The aim is to detect eosinophil subtypes in peripheral blood based on surface protein expression, to understand the differences in eosinophil subtypes among patients with different diseases, to elucidate the significance of different eosinophil subtypes, and ultimately to provide a theoretical basis for the selection of treatment directions for patients.


Eligibility criteria: Inclusion Criteria:

* For Healthy Volunteers: healthy volunteers matching the age and gender of the study subjects
* For EPD: ① Persistent eosinophil count increase\>1500 per cubic millimeter for more than 6 months. ② Lack of evidence of a secondary cause of eosinophilia is required. ③ Signs and symptoms of end-organ damage presumed to be secondary to eosinophilia

Exclusion Criteria:

* Patients with concurrent definitive pulmonary infections, malignancies, or other parenchymal lung diseases;
* Patients who are unable or unwilling to cooperate with the collection of clinical information (e.g., due to mental disorders, memory impairments, etc.);
* Patients who are unable to provide informed consent.

Primary outcomes:
measure: Proportion of Eosinophil Subtypes in Serum
timeFrame: From January 1, 2024 to January 1, 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT04096118: Relationship Between Lymph Node Ratio and Survival Rate in Preoperative Chemoradiation Rectal Cancer Patients
Official title: Relationship Between Lymph Node Ratio and Survival Rate in Preoperative Chemoradiation Rectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal cancer
Lymph node after neoadjuvant rectal cancer
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectal cancer who underwent curative surgery following neoadjuvant chemoradiation.

Brief summary: Colorectal cancer is the most-common cancer of the gastrointestinal tract. The number of positive lymph nodes and total number of lymph nodes retrieved are important prognostic factors. In patients who do not receive preoperative chemoradiation, the total number of lymph nodes should be more than 12 nodes to predict accurate staging. In cases of locally-advanced rectal cancer when patients receive neoadjuvant chemoradiation it is sometimes impossible to retrieve adequate amount of lymph nodes due to the chemoradiation effect. Therefore, this study was to evaluate and predict survival rates based on positive lymph node ratio.

Detailed description: The primary endpoint of this study was to assess the lymph node ratio as another predictor for survival rate in preoperative chemoradiation rectal cancer patients. The other secondary objective was to determine the relationship between total harvested lymph nodes and survival rate in each stage. This is a retrospective, single-centered study, collecting data of patients from January 2011 to December 2017. Including a total of 163 patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation. Using Cox regression and Kaplan-Meier survival analysis to determine whether the lymph node ratio can be used to predict the survival rate and determine the cut-off value to distinguish the prognosis of the disease.

Eligibility criteria: Inclusion Criteria:

* Patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation.
* Patients have tissues confirmed by Pathology
* no metastasis before surgery

Exclusion Criteria:

* Distant metastasis during surgery

Primary outcomes:
measure: Survival rates
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chairat Supsamutchai
state: Bankok
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Chairat Supsamutchai, MD
role: STUDY_CHAIR
affiliation: of Medicine Ramathibodi Hospital, Mahidol University.
name: Tanet Chatmongkonwat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04358718: Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy
Official title: Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Circulating tumor cells
Opioid
Epidural anesthesia
Radical cystectomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 44
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: Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.


Eligibility criteria: Inclusion Criteria:

* Age \>=18
* ASA I-II
* Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Palliative surgery
* Contraindications for epidural anesthesia
* Metastatic bladder cancer
* Patients with a history of any other malignancy
* Chronic opioids medication
* severe systemic disease (heart, lung, kidney, or immune system)
* Known hypersensitivity or suspected allergy to intervention drugs
* Intellectual Disability

Primary outcomes:
measure: the number of circulating tumor cells
timeFrame: on the 3rd day after surgery
Secondary outcomes:
measure: the number of circulating tumor cells
timeFrame: immediately after the surgery
measure: the number of circulating tumor cells
timeFrame: on the 30 day after surgery
measure: Visual Analogue Scale
timeFrame: at 24 hours after surgery
measure: Visual Analogue Scale
timeFrame: at 48 hours after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
References:
Clinical trial NCT06064318: Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study
Official title: Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Replacement
Knee Replacement Revision
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Bispebjerg Hospital
First posted: 2023-10-03
Enrollment: 161384
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Danish residents who received a primary knee arthroplasty in Denmark between 1998-2021.

Brief summary: The purpose of this study is to investigate the incidence and prevalence rates of multiply revised knee arthroplasty patients in Denmark from 1998-2021.


Eligibility criteria: Inclusion Criteria:

* Danish Resident
* all ages
* must have had primary knee arthroplasty procedure performed in Denmark between 1998-2021

Exclusion Criteria:

* Missing key variables (patient ID, date of surgery, procedure-code, laterality of procedure)
* Duplicates
* Non-relevant procedures

Primary outcomes:
measure: Prevalence of major n-grade revisions
timeFrame: 23 years
measure: Incidence of major n-grade revisions
timeFrame: 23 years
measure: Prevalence of all n-grade revisions
timeFrame: 23 years
measure: Incidence of all n-grade revisions
timeFrame: 23 years
Secondary outcomes:
measure: Incidence of major and all n-grade revisions stratified by sex and age
timeFrame: 23 years
measure: Prevalence of major and all n-grade revisions stratified by sex and age
timeFrame: 23 years
measure: Prevalence of major and all n-grade revisions for patients with their total sum of revisions
timeFrame: 23 Years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: