louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05869838: A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies
Official title: Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD (Computer Aided Detection) System: a Prospective, Multicenter, Post-market Investigation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Polyp
Lead sponsor: Olympus Europe SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing screening or surveillance colonoscopy

Brief summary: The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

Detailed description: The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
* Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

Exclusion Criteria:

* Patients for whom endoscopic submucosal dissection is planned
* Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
* Patients who have to receive an urgent colonoscopy procedure
* Patients who underwent total colectomy of the large intestine
* Patients who are judged by a physician to be contraindicated for colonoscopy procedures
* Patients who have participated in another clinical study within the last 30 days

Primary outcomes:
measure: Videos and still images of the colonoscopy
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: End- und Dickdarmzentrum Hannover
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Stockholm
country: Sweden
facility: Ersta Hospital Stockholm
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Sofía Parejo Carbonell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517138: Right-front Direction in Parabolic Flight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged between 20-65 years
* Affiliates to a social security system
* Who are willing to take part in the study,
* Who gave written informed consent,
* Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.

Exclusion Criteria:

* People who participated in a biomedical research protocol for which the exclusion period is complete,
* pregnant women.

Primary outcomes:
measure: eye movements
timeFrame: Baseline
measure: acceleration of the head
timeFrame: Baseline
measure: perception by the subjects of the right-front.
timeFrame: Baseline
measure: acceleration of the arms
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT05002738: Desogestrel-containing COCP Pharmacokinetic Validation Study
Official title: Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). The original pharmacokinetic studies were performed with a levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with a desogestrel-containing oral contraceptive pill.

Detailed description: Enrolled participants will be started on a standard pack of desogestrel-containing oral contraceptive pills and undergo an intensive pharmacokinetic study visit on day 21 of the pill pack. This will entail 11 serial blood draws and a final blood draw the next day at 24 hours post-pill intake to measure and calculate a pharmacokinetic area under the curve for both the estrogen and progestin components of the pill. We will then correlate the 24-hour trough measurement to the area under the curve measures to determine the correlation of these measurements.

Eligibility criteria: Inclusion Criteria:

* Healthy females aged 18-45 years
* Body-mass index ≥18.5kg/m2
* Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
* Normal blood pressure measurement at screening (systolic \<140mmHg, diastolic \<90mmHg)
* Negative urine pregnancy test at screening

Exclusion Criteria:

* Currently taking any known CYP3A4 inducers/inhibitors
* Medical conditions that affect liver function (e.g. hepatitis, cirrhosis)
* Any contraindications to estrogen-containing contraception (based on any category 3 or 4 recommendations from the CDC MEC guidelines)
* Use of an injectable contraceptive method within the last 6 months or current use of an ENG contraceptive implant
* Childbirth within the last 6 months
* Known allergy or insensitivity to combined oral contraceptive pills

Primary outcomes:
measure: Serum Etonogestrel Concentrations
timeFrame: 24 hours
measure: Serum Ethinyl Estradiol Concentrations
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
References:
Clinical trial NCT00789438: Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia
Official title: The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Pain
Keywords: Analgesia
Sedation
Spinal
Stress
Surgical
Surgical Stress
Pain
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for short-term (30-90 min) surgery.

Brief summary: The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.

Detailed description: 1. Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SPI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block.
2. Increasing SPI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation.
3. In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.

Eligibility criteria: Inclusion Criteria:

* surgical procedures feasible under general or spinal anesthesia
* duration between 30 and 90 min
* ASA status I,II or III

Exclusion Criteria:

* contraindications against one of the anesthesia methods
* age under 18
* emergencies
* chronical pain history
* lack of sinus rhythm

Primary outcomes:
measure: Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints
timeFrame: Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: Institut für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
name: Berthold Bein, PD Dr med
role: STUDY_DIRECTOR
References:
Clinical trial NCT00872638: The Effect of Wound Edge Eversion on Cosmesis
Official title: The Effect of Wound Edge Eversion on Cosmesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgical Incisions
Keywords: wound edge eversion
cosmetic outcomes
surgical incisions
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Aesthetic appearance of repaired incisions is very important to surgical patients. It has been stated that if the edges of a wound are closed in such a manner that will result in eversion, or pouting of the edges that the end cosmetic result will be superior when compared to wound edges that are simply approximated. The purpose of this study is to compare cosmetic outcomes of incisions that are closed with everted edges to those in which the edges are simply approximated.

Detailed description: Surgical incisions will be split into two halfs and each half will be randomized to standard or everting sutures. 3 months later the cosmetic outcome of the healed wounds will be determined using a validated scar evaluation scale.

Eligibility criteria: Inclusion Criteria:

* age over 18.
* able to consent.
* scheduled for elective plastic or cardiothoracic surgery.

Exclusion Criteria:

* history of keloids, hypertrophic scarring, diabetes, or peripheral vascular disease.
* those requiring systemic steroids or undergoing chemotherapy, and those unable or unwilling to consent.

Primary outcomes:
measure: Cosmetic result of surgical incision as measured by VAS scale
timeFrame: 1 year
Secondary outcomes:
measure: Cosmetic Results as measured by the Stony Brook Scar Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Adam Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278938: Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders
Official title: Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Depressive Illness
Keywords: depression
citalopram
bupropion
combination therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion
Primary purpose: TREATMENT

Brief summary: Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.

Detailed description: Participants in another study who did not remit during 12 weeks treatment with citalopram (to 40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450 mg/d) added for six weeks.

Eligibility criteria: Inclusion Criteria:

* non-remission in Protocol #6559R
* age 18-66
* signs informed consent
* physically healthy

Exclusion Criteria:

* bipolar disorder
* history of psychosis
* history of anorexia nervosa or bulimia
* history of seizure disorder, significant brain trauma or other medical reason to suspect increased seizure risk

Primary outcomes:
measure: Hamilton Rating Scale
timeFrame: weeks 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Research Psychiatrist II at New York State Psychiatric Institute
name: Jonathan W Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04136938: Social Marketing in Prevention Actions
Official title: Impact of Social Marketing in Collective Prevention Actions : Case of Fall Prevention Workshop Among Elderly Living in Three French Departments.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedentary Behavior
Aging
Keywords: Fall
Seniors
Physical activity
Prevention
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Crédit Agricole Loire / Haute-Loire
name: Jean Monnet University
First posted: 2019-10-23
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People aged 60 and over.

Brief summary: Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation and attendance resulting in Physical Activity (PA) approaches designed to prevent falls actually only benefiting a limited number of elderly subjects. Social marketing has already shown its utility in the construction of prevention programs.

Detailed description: This study uses the social marketing approach to improve a fall prevention program. The intervention territory will receive social marketing campaign while the territory controls will not have a campaign.

The main goal is to improve attendance at our fall prevention program.

Eligibility criteria: Inclusion Criteria:

* People living in the one of the territories of the study
* People without medical contraindications to participate in moderate physical activity
* People who has received information about the study and its rights to its data

Exclusion Criteria:

* People unable to attend workshops
* People already registered for adapted physical activity
* People who refused to participate to the study.

Primary outcomes:
measure: Rate of attendance rate of participants at social marketing campaign (%)
timeFrame: Years: 1
Secondary outcomes:
measure: Rate of attendance rate of participants at fall prevention workshop sessions (%)
timeFrame: Years: 1
measure: Life quality of participants measured by SF-36 questionnaire score
timeFrame: Years: 0, 1
measure: Physical activity level of participants measured by IPAQ questionnaire
timeFrame: Years: 0, 1
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: Jean Monnet University
name: Luc GOETHALS, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goethals L, Barth N, Hupin D, Chapoton B, Guyot J, Celarier T, Roche F, Gallopel-Morvan K, Bongue B. Social Marketing Intervention to Engage Older Adults in Balance Workshops for Fall Prevention: A Multicenter Quasi-Experimental Protocol Study. Front Public Health. 2021 Jul 14;9:614119. doi: 10.3389/fpubh.2021.614119. eCollection 2021.
Clinical trial NCT02248038: A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery
Official title: A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
name: Nanfang Hospital, Southern Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Peking Union Medical College Hospital
First posted: 2014-09-25
Enrollment: 1300
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Detailed description: Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Study design：Randomized parallel control

Eligibility criteria: Inclusion Criteria:

1. informed consent
2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line
3. cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm
4. age less than 80 years old
5. normal blood routine test and hepatic or renal function test
6. no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction.

Exclusion Criteria:

1. severe comorbidity such as heart attack or stroke, malignance in 5 years
2. can not tolerate to general anesthesia, pneumoperitoneum or surgery
3. pregnant or during breast-feeding period
4. attending other clinical trial involving therapy
5. cannot or disagree to attending the clinical trial

Primary outcomes:
measure: 5 years diseases free survival rate
timeFrame: five years
measure: 5 years overall survival rate
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Guobin Wang, MD,PhD
role: STUDY_CHAIR
affiliation: Wuhan Union Hospital, China
name: Kaixiong Tao, MD,PhD
role: STUDY_DIRECTOR
affiliation: Wuhan Union Hospital, China
name: Kailin Cai, MD,PhD
role: STUDY_DIRECTOR
affiliation: Wuhan Union Hospital, China
name: Shi Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04673838: The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
Official title: The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to assess the effect of lower limb sensory training on proprioception, balance, gait and motor functions in Hemiparetic Individuals.

Detailed description: After being informed about the study, all patients giving written informed consent will be determined eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a single-blind manner (investigor about assessments). A group will have Bobath Therapy and the other group Bobath and Sensory Training.

Eligibility criteria: Inclusion Criteria: for Intervention and Control Group:

* Between the ages of 20-65 and discharged from the hospital,
* Having been diagnosed with hemiparesis at least 4 weeks ago,
* First time and one-sided hemiparesis,
* Modified Rankin Score ≤3,
* Hodkinson Mental Test ≥ 6,
* Individuals who agree to having treatment will be included in the study.

Exclusion Criteria:for Intervention and Control Group:

* Having vision and hearing problems,
* Having other neurological, psychiatric and / or orthopedic problems other than hemiparesis,
* Medically unstable,
* Have other diagnosed diseases that will affect lower extremity sensation,
* Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.

Primary outcomes:
measure: Functional Level
timeFrame: 4 weeks
measure: Foot Sole Sense
timeFrame: 4 weeks
measure: Lower Extremity Position Test
timeFrame: 4 weeks
measure: Kinesthesia Sense
timeFrame: 4 weeks
measure: Balance Assessment
timeFrame: 4 weeks
measure: Evaluation of Gait Parameters
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Gulsum Tikac, MSc Pt
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Filiz Altuğ, Prof Dr
role: STUDY_DIRECTOR
References: