louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05801172: Managing Outpatient Hysteroscopy-associated Pain
Official title: Relieving Outpatient Hysteroscopy-associated Pain: What is the Most Effective Method?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Hysteroscopic Surgery
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine).
Primary purpose: TREATMENT

Brief summary: Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.

Detailed description: A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.

Eligibility criteria: Inclusion Criteria:

* age over 18
* indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility

Exclusion Criteria:

* allergies to medications
* refusal to consent to the procedure or participation in the study

Primary outcomes:
measure: Intensification of pain in Numeric Rating Scale: 0-10
timeFrame: up to 6 months
Secondary outcomes:
measure: Intensity of cervical bleeding on the assumed scale: 0-3
timeFrame: up to 6 months
measure: Occurrence of vaso-vagal reaction during the procedure
timeFrame: up to 6 months
measure: Occurrence of abandoning/ limiting the procedure
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Study officials:
affiliation: Jagiellonian University
name: Robert Jach, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03025672: Evaluation of the Cost of a Nosocomial Infection With Clostridium Difficile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cross Infection
Clostridium Difficile Infection
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 10445
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have stayed in an hospital of the GHICL in 2013 and 2014

Brief summary: Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode of transmission and its resistance in the environment.

Nosocomiality is defined by the apparition of an infection 48 hours after the patient's hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted directly through the hand or from the contaminated environment (during care or not). By implementing prevention and optimal treatment, nosocomial infections are preventable.

A clostridium difficile infection causes an additional cost of patient care for the hospital. This additional cost is principally due to the increase of the length of the stay. It varies according to patient risk factors,and also according to the reason of the hospitalization and can vary from 300 euros (\~317$) to more than 25.000 euros (26.460$).

By determining the increase in the length of the stay and the additional cost due to a clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut Catholique de Lille), prevention will be valued and measures against those infections should be easier to set up.

The main objective of this study is to evaluate the additional cost of an infection by clostridium difficile.


Eligibility criteria: Inclusion Criteria:

* Patients that have stayed in an hospital of the GHICL between January 2013 and September 2015.

Exclusion Criteria:

* none

Primary outcomes:
measure: Difference between patient cost and income for the hospital based on the PMSI rate.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04220372: Tongxinluo Capsule for Coronary Microvascular Disease
Official title: The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Microvascular Disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-01-07
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 investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility criteria: Inclusion Criteria:

1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
2. Coronary normal or stenosis \< 20%;
3. Ischemic depression in ST segment during resting or exercise;
4. Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
5. Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

1. Previous myocardial infarction or PCI or CABG treatment;
2. A history of heart failure or LVEF \< 50%;
3. Severe arrhythmia;
4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
5. A history of stroke within half a year;
6. Diabetes difficult to control;
7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm;
8. Familial hypercholesterolemia;
9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;
10. Pregnant or nursing, or having the intention to give birth within one year;
11. Hepatic or renal dysfunction;
12. Other diseases which may cause serious risks to patients;
13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
14. Allergic to contrast agents or blood products;
15. Patients who participated in clinical research of other drugs within 3 months before being selected.

Primary outcomes:
measure: Changes of Coronary Flow Reserve
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04137172: Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
Official title: Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: ventral hernia - LVHR-transfacial repair
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-10-23
Enrollment: 177
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: entral hernias are a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5 % in the literature, and ventral incisional hernia rates vary from 35 to 60 % within 5 years after laparotomy . After laparoscopy, this rate is estimated to decline from 0.5 to 15 % even after two decades, LVHR or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position. . The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with IPOM reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years undergoing surgery for primary or incisional ventral hernia
* defect whose major axis not exceeding 12cm.

Exclusion Criteria:

* Patients undergoing revision
* Emergency surgery.
* Parastomal hernias were not included.
* Patients not candidate for laparoscopy including cardiac and COPD patients

Primary outcomes:
measure: post operative complications
timeFrame: 6 months
Secondary outcomes:
measure: adequacy of different techniques
timeFrame: 6 months to one year
measure: Surgical Site Occurrence (SSO)
timeFrame: 6 months to one year
measure: Hernia Reoccurence
timeFrame: 6 months to one year
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig Unversity
Study officials:
References:
Clinical trial NCT01417572: Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Retinal Detachment
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.


Eligibility criteria: Inclusion Criteria:

* Retinal detachment
* Retinal tear less than 3 hour clock

Exclusion Criteria:

* Vitreous hemorrhage
* Proliferative vitreoretinopathy

Primary outcomes:
measure: intraoperative heart rate measurement
timeFrame: 6 month
measure: decrease in pain and nausea,vomiting after surgery
timeFrame: 6 month
measure: decrease in ocr after application of topical lidocaine
timeFrame: 6 month
measure: postoperative nausea and vommitting
timeFrame: 6 month
measure: postoperative pain
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
References:
Clinical trial NCT01647672: Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer
Official title: A Study to Assess the Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in the Treatment of Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Detailed description: The investigators select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Eligibility criteria: Inclusion Criteria:

1. Karnofsky ≥ 70
2. Provision of informed consent
3. Pathological confirmation of breast cancer
4. Tumor stage (TNM):T2-4bN0-3M0
5. Measurable disease as per RECIST criteria
6. Not previously treated with radiotherapy, chemotherapy or biological therapy.
7. Laboratory criteria:

   * PLT ≥ 100\*109/L
   * WBC ≥ 4000/mm3
   * HGB ≥ 10g/dl
   * GOT,GPT,ALP ≤ 2\*ULN
   * TBIL,DBIL,CCr ≤ 1.5\*ULN

Exclusion Criteria:

1. Pregnant woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy

Primary outcomes:
measure: therapeutic assessment
timeFrame: 6 months
Secondary outcomes:
measure: Adverse reactions and disease-free survival
timeFrame: 2 year
Other outcomes:
measure: Recurrence or death
timeFrame: 5 years
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Cancer Hospital
name: Jin Zhang, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06952972: MorphECOS - Evaluation of the Influence of Fatigue and Sleep on the Performance of 2nd Cycle Medical Students (OSCE)
Official title: MorphECOS - Evaluation of the Influence of Fatigue and Sleep on the Performance of 2nd Cycle Medical Students (OSCE): a Single-centre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue Intensity
Sleep
Sleep Deprivation
Circadian Rhythm
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2nd cycle médical program

Brief summary: Objective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is a challenge for medical students.

The aim of this study is to better characterise the population of students taking the OSCEs on the subject of sleep and fatigue and to assess whether these factors have an impact on their performance in the OSCEs.


Eligibility criteria: Inclusion Criteria:

* Subjects of legal age, enrolled in the 2nd cycle médical program at the Lyon Est Faculty of Medicine (Claude Bernard Lyon 1 University), taking part in the annual session (February or March 2025) of the faculty's OSCEs and having agreed to participate by completing and signing the dedicated written consent form.

Exclusion Criteria:

* abstenteism or Premature end to the OSCE session.

Primary outcomes:
measure: PERFORMANCE
timeFrame: obtained seven days after the objectif structured clinical examination
Secondary outcomes:
measure: Significant difference in student performance per station and per item
timeFrame: obtained seven days after the objectif structured clinical examination
measure: Significant difference in Visual Analog Scale response according to the different profiles
timeFrame: Two times : 1 hour before and 1 hour after the OSCE session
Other outcomes:
Locations:
city: Lyon
country: France
facility: Claude Bernard University
Study officials:
References:
Clinical trial NCT00398372: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
Official title: Le20: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Lymphomas: Non-Hodgkin
Lymphomas: Non-Hodgkin Cutaneous Lymphoma
Lymphomas: Non-Hodgkin Diffuse Large B-Cell
Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell
Lymphomas: Non-Hodgkin Mantle Cell
Lymphomas: Non-Hodgkin Marginal Zone
Lymphomas: Non-Hodgkin Peripheral T-Cell
Lymphomas: Non-Hodgkin Waldenstr Macroglobulinemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Amgen
name: National Institutes of Health (NIH)
First posted: 2006-11-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.


Eligibility criteria: Inclusion Criteria:Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment

Primary outcomes:
measure: To characterize the molecular and cell biology of the tumor cells in lymphoma.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Wen-Kai Weng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807672: Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer
Official title: MARF-E- Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that undergo to clinics/hospitalization examination at Fondazione Policlinico Universitario "A. Gemelli" IRCCS for endometrial cancers will be candidate to partecipate to this study, according to exclusion and inclusion criteria.

Brief summary: In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven endometrial cancer;
* Women aged \> 18 years old;
* Signed Informed consent.

Exclusion Criteria:

* Previous history of neoplasm;
* Concurrent malignancies at other sites.

Primary outcomes:
measure: Association between T1-, T2- and diffusion-mappings and risk group classification
timeFrame: 3 months
Secondary outcomes:
measure: Diagnostic accuracy of T1-,T2- and diffusion-mappings deriving from MRF in myometrial invasion detection
timeFrame: 3 months
measure: Correlation between T1-, T2- and diffusion mappings and DFS and OS
timeFrame: 3 years
measure: Diagnostic accuracy of T1-,T2- and diffusion-mappings and pathological nodal involvement
timeFrame: 3 months
measure: Evaluation of Radiomic and Radiogenomic models to predict recurrence in early stage EC and to predict DFS and OS
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Study officials:
References:
Clinical trial NCT01234272: Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-
Official title: Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer
Keywords: patients with
undergoing
gastrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.


Eligibility criteria: Inclusion Criteria:

* I or II of preoperative physical status classification by the American Society of Anesthesiologists.
* more than 20 years old.
* undergoing gastrectomy due to gastric cancer.

Exclusion Criteria:

* contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly.
* prior history of abdominal surgery or spine surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital, Department of Anesthesia and Pain Medicine
name: Bon-Nyeo Koo, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: