louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00512044: Local Versus General Anaesthesia in Stapled Hemorrhoidectomy
Official title: Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hemorrhoids
Keywords: anesthesia, Longo, mucosectomy, hemorrhoids
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether local or general anaesthesia in stapled hemorrhoidectomy leads to a shorter operation time with a better patient comfort.

Detailed description: Hemorrhoids are a frequent disease with the need of surgical intervention in 10-20% of the patients. The stapled hemorrhoidectomy according to Longo under general anesthesia (or spinal) is considered standard of care \[1\]. Cohort studies show that a pudendal bloc with local anesthesia is safe and efficient \[2-4\]. The majority of procedures are actually performed in private clinics or in an ambulatory setting underlining the importance of economic issues such as procedure time (anesthesia and operation time) and hospital stay.

We hypothesize that stapled hemorrhoidectomy under local anaesthesia shortens anaesthesia time and hospital stay and reduces costs with no disadvantages regarding pain, satisfaction and complication rate.

Eligibility criteria: Inclusion Criteria:

* Hemorrhoids grade III suitable for elective stapled hemorrhoidectomy

Exclusion Criteria:

* Age \< 18 years
* No informed consent
* Emergency situation
* Contraindication to either anaesthesia method
* Patients not speaking french or german.
* Additional anal pathology (fissure, tumour).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital Center
Study officials:
affiliation: Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
name: Nicolas Demartines, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03439644: Physiological Upper Eyelid Laxity
Official title: Physiological Upper Eyelid Laxity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Laxity
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This is a prospective, single-center study in normal subjects aged 20 to 89 years.

The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old) measured with the method of McNab and studying it according to her customary side of sleep. In addition, we evaluated a method for measuring tarsal laxity.


Eligibility criteria: Inclusion Criteria:

* 20 to 89 years
* be free
* be able to give informed consent

Exclusion Criteria:

* History of facial paralysis, upper palpebral trauma or palpebral surgery
* History of sleep apnea syndrome
* Impossibility to give consent
* Pregnant or lactating women
* Persons enjoying enhanced protection and persons deprived of their liberty by a judicial or administrative decision

Primary outcomes:
measure: Evolution of upper eyelid laxity
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU DE Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Roxane FLAUSSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189644: 6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Association Européenne de Recherche en Oncologie
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
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 main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.


Eligibility criteria: Inclusion Criteria:

* Histologically proven cancer of the breast,
* Mastectomy or complete tumorectomy,
* Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
* Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy \< 2 months,
* Biological criteria (before the first FEC cycle):

  * Neutrophils \>1.5 109 /L
  * Platelets \>100 109/L
  * Hemoglobin \>10 g/dl
  * Creatininemia \<120 mmol/1
  * Bilirubinemia \<1.5 Upper normal value
* Female patients over 18 years old
* Written and signed informed consent
* Performance Status less than or equal to 2 (WHO scale, see Annex IV)

Exclusion Criteria:

* Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
* Bilateral breast cancer or history of contralateral breast cancer
* Cardiac history: cardiac insufficiency (LVEF \<50%) or coronary decompensation
* Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
* Inflammatory breast cancer
* Distant metastasis or supraclavicular adenopathy
* Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years
* Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol
* Psychiatric pathology
* Patient participating in another trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Association Europeenne de Recherche en Oncologie
name: Pascal Piedbois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Association Europeenne de Recherche en Oncologie
name: Anne-Chantal Braud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Association Europeenne de Recherche en Oncologie
name: Daniel Serin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05088044: A Study to Assess the Impact of Implementing Modified Early Warning Score in Terms of Competency and Self-efficacy of Nurses at ILBS, Delhi
Official title: A Quasi Experimental Study to Assess the Impact of Implementing Modified Early Warning Score in Terms of Competency and Self-efficacy of Nurses at ILBS, Delhi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one group pre-test post-test design.
Primary purpose: PREVENTION

Brief summary: In this study nurses will be taught regarding Modified Early Warning Score and how to mark the involved physiological parameters in the MEWS chart and then scoring will be given i.e MEWS score and according to the score intervention would be taken by nurses by communicating with other health team members. this scoring will allow nurses to assess early deterioration and early ICU admission and at last nurses will be asked regarding the barriers or facilitators they faced while performing MEWS score.


Eligibility criteria: Inclusion Criteria:

* registered nurses working in general, semi-private and private ward nurses willing to participate

Exclusion Criteria:

* registered nurses who will not be present at the time of data collection. pull out staffs.

Primary outcomes:
measure: to assess the impact of MEWS on competency and self-efficacy of nurses before and after implementing MEWS
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT03180944: Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining
Official title: Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucosal Irritation
Image Quality
Keywords: Lugol's solution
esophageal squamous cell cancer
mucosal irritation
image quality
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study was to test an optimal concentration of Lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial.

Detailed description: It is widely accepted that chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation. The conventional concentration of Lugol's solution is in the range of 1.2% to 2.5% . Image quality can be guaranteed with this range of Lugol's solution. However, lead to retrosternal pain and discomfort, and can even induce erosion or ulceration in the esophagus and stomach. This study was to test whether a lower concentration of Lugol's solution, which has minimal mucosal irritation, can provide satisfied image quality by a randomized blinded controlled trial.

Eligibility criteria: Inclusion Criteria:

* patients in the high-risk population of ESCC;
* or general risk population of ESCC between 40 to 74 years old. Definition of high-risk population of ESCC is list in supporting information33.

Exclusion criteria included the following:

* with obvious abnormalities in stomach, confirmed by either white-light endoscopy (WLE) or pCLE, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, H. pylori infection and severe bile reflux gastritis;
* advanced esophageal carcinoma;
* known esophageal surgery or endoscopic treatment;
* known esophageal radiotherapy or chemotherapy;
* esophageal stenosis;
* food retention;
* allergy to iodine or fluorescein sodium;
* hyperthyroid;
* coagulopathy;
* acute bleeding;
* severe organ failure;
* pregnant or breastfeeding women.

Primary outcomes:
measure: Image Quality
timeFrame: intraoperative
Secondary outcomes:
measure: Gastric Mucosa Injury
timeFrame: 1 months
measure: Adverse Events
timeFrame: 24 hours
measure: Severe Adverse Events
timeFrame: 24 hours
measure: Tolerance
timeFrame: intraoperative
measure: Histology analysis
timeFrame: 3-5days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791292: Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain
Official title: Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: Pressure pain threshold
Neck
Neck pain
Hand grip strength
Quality of life
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case control study
Primary purpose: OTHER

Brief summary: This study will be determined whether the pressure pain threshold and hand grip strength are affected in individuals with neck pain compared to individuals without neck pain.

Detailed description: When the literature is examined, there are studies examining different parameters in different occupations, men and women with neck pain, individuals with cervical disc hernia, and individuals with chronic neck pain. Studies have addressed different parameters that may be associated with neck pain from different perspectives. However, no study was found in which the pressure pain threshold and hand grip strengths were determined and the relationship was examined in individuals with and without chronic neck pain. Therefore, with this study, it will be determined whether the pressure pain threshold and hand grip strength are affected in individuals with neck pain compared to individuals without neck pain.

Eligibility criteria: Inclusion Criteria:

* Having neck pain complaint for more than three months,
* Without any diagnosed chronic disease,
* Have no past or present psychological disorders,
* Individuals who can speak, read and write Turkish.

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder,
* Individuals who cannot speak, read or write Turkish.

Primary outcomes:
measure: Hand grip strength
timeFrame: 1 day
measure: Neck disorder
timeFrame: 1 day
measure: Arm, shoulder, and hand problems
timeFrame: 1 day
measure: General quality of life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT01115192: Blephacura Versus Baby Shampoo to Treat Blepharitis
Official title: Blephacura Versus Baby Shampoo to Treat Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharitis
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Optima Pharmazeutische GmbH
First posted: 2010-05-04
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness in treatment of chronic blepharitis either with a phospholipid liposome suspension compared to a conventional therapy recommendation using diluted baby shampoo.


Eligibility criteria: Inclusion Criteria:

* patients with blepharitis
* 100 eyes of 100 patients (50 patients treated with Blephacura, 50 patients treated with diluted baby shampoo) The ratio of female / male is not involved.

Exclusion Criteria:

* all patients that are not included in the group of inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Eye Hospital, University of Cologne
state: NRW
Study officials:
References:
Clinical trial NCT06998992: Assessing the Reliability of Self-Reported Hepatitis B Vaccination Status in Outpatients: Evaluation of Individuals Born in France and Consulting at the CeGIDD in Saint-Denis.
Official title: Assessing the Reliability of Self-Reported Hepatitis B Vaccination Status in Outpatients: Evaluation of Individuals Born in France and Consulting at the CeGIDD in Saint-Denis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Vaccination
Health Knowledge, Attitudes, Practice
Serologic Tests
Ambulatory Care
Public Health
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be adults born in France who attend the CeGIDD (sexual health clinic) at Delafontaine Hospital in Saint-Denis. These individuals are seeking care and require a hepatitis B serology test. The population includes people with diverse backgrounds in terms of age, sex, sexual orientation, and education level. Patients with a known history of past hepatitis B infection will be excluded. The study focuses on evaluating the reliability of their self-reported hepatitis B vaccination status compared to serological test results.

Brief summary: This study aims to find out whether people accurately know their hepatitis B vaccination status. It focuses on individuals born in France who visit a sexual health clinic (CeGIDD) in Saint-Denis. During the consultation, each person is asked whether they think they are vaccinated against hepatitis B. Then, a blood test is done to check if they really are. The goal is to see how often people's answers match their actual medical status. The study also looks at factors like age, gender, education level, and whether they have a regular doctor to understand who is more likely to be unsure or mistaken about their vaccination status. About 200 participants are expected to take part.


Eligibility criteria: Inclusion Criteria:

* Patients born in France.
* Consulting at the CeGIDD of Delafontaine Hospital in Saint-Denis.
* Requiring a hepatitis B serology test.

Exclusion Criteria:

- Patients with a history of past hepatitis B infection.

Primary outcomes:
measure: The percentage of patients who declared being vaccinated against hepatitis B and who are confirmed to be truly vaccinated by serology.
timeFrame: July 2020 - October 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT01210092: Comparison of Different Video Laryngoscopes in a Manikin With Immobilized Cervical Spine
Official title: Comparison of Different Video Laryngoscopes in a Manikin With Immobilized Cervical Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Intubation
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anaesthesiologists

Brief summary: To determine whether different video laryngoscopes facilitate intubation in an manikin with immobilized cervical spine compared with standard laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* anaesthesiologist
* experienced in tracheal intubation

Exclusion Criteria:

* missing experience in tracheal intubation
* missing informed consent

Primary outcomes:
measure: successful tracheal intubation
timeFrame: max 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Anaesthesiology and Postoperative Critical Care
Study officials:
affiliation: Department of Anaesthesiology, University of Cologne
name: Wolfgang A Wetsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01839292: ComVi and D-type Stent in Malignant GOO
Official title: A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Outlet Obstruction
Keywords: gastric outlet obstruction
palliative treatment
stent
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
name: Kyungpook National University Hospital
name: Hallym University
name: The Catholic University of Korea
name: Seoul National University
name: DongGuk University
First posted: 2013-04-24
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.


Eligibility criteria: Inclusion Criteria:

* adults 18 years of age or older
* obstructive symptoms due to unresectable malignant GOO
* a Karnofsky performance score of more than 30 (13)

Exclusion Criteria:

* history of a previous SEMS insertion
* the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
* severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
* a life expectancy of less than 1 month after SEMS insertion
* history of gastric surgery

Primary outcomes:
measure: the stent patency time from stent insertion to restenosis due to stent malfunction or death
timeFrame: Up to 1 years
Secondary outcomes:
measure: stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate
timeFrame: up to 1 years
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Jin Hong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313792: Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation
Official title: Efficacy, Safety and Quality of Life of Palifermin on Reducing Oral Mucositis in Patients With Hematopoietic Stem Cell Transplantation, Prospective Double-blind Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mucositis
Keywords: Hematopoietic stem cell transplantation
Palifermin
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: BLNH
First posted: 2014-12-10
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care.


Eligibility criteria: Inclusion Criteria:

* adequate organ function
* patients who will receive autologous stem cell transplantation
* patients who will receive allogeneic stem cell transplantation using myeloablative conditioning regimen

Exclusion Criteria:

* presence of concomitant malignancy
* presence of active infection or oral mucositis prior to stem cell transplantation
* any conditions where the severity of oral mucositis cannot be evaluated

Primary outcomes:
measure: Duration of severe oral mucositis after stem cell transplantation
timeFrame: 5 weeks
Secondary outcomes:
measure: Incidence of severe oral mucositis after stem cell transplantation
timeFrame: 5 weeks
measure: Average VAS score during severe oral mucositis
timeFrame: 5 weeks
measure: Requirement of opioid drugs during severe oral mucositis
timeFrame: 5 weeks
measure: Requirement of opioid drugs
timeFrame: 5 weeks
measure: Cost effectiveness of palifermin during stem cell transplantation
timeFrame: 5 weeks
measure: Quality of life during transplant period
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
References: