louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06943417: Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction
Official title: Safety and Efficacy of Endoscopic Full Thickness Biopsy With Over the Scope Clip in Patients With Chronic Intestinal Pseudo-obstruction: A Single-Center, Single-Arm, Open-label, Interventional Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Intestinal Pseudo-obstruction
Keywords: Chronic intestinal pseudo-obstruction
Endoscopic full thickness biopsy
Lead sponsor: International University of Health and Welfare
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction
* Patients who are 18 years of age or older at the time of obtaining consent
* Gender: Any

Exclusion Criteria:

* Patients for whom it is difficult to perform endoscopy
* Patients who cannot obtain consent
* Patients with serious renal, hepatic, or cardiac disease
* Patients who are participating in other clinical research, except for observational research.
* Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.

Primary outcomes:
measure: Percentage of total perforations (intraoperative and delayed perforations)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Intraoperative perforation rate
timeFrame: Under procedure
measure: Rate of delayed perforation
timeFrame: Periprocedural
measure: Intraoperative complications
timeFrame: Under procedure
measure: Intraoperative death rate
timeFrame: Under procedure
measure: Examination time
timeFrame: Under procedure
measure: Macroscopic specimen size
timeFrame: Immediately after procedure
measure: Findings of tissue specimens
timeFrame: Immediately after procedure
measure: Whether tissue evaluation is acceptable for biopsy purposes
timeFrame: Immediately after procedure
measure: Ratio of postoperative complications
timeFrame: Immediately after procedure
measure: Time or days of fluid intake postoperatively
timeFrame: From date of procedure until the date of first fluid intake assessed up to 12 months
measure: Time or number of days of food intake after procedure
timeFrame: From date of procedure until the date of first food intake assessed up to 12 months
measure: Length of hospital stay
timeFrame: From date of procedure until the date of discharge assessed up to 12 months
Other outcomes:
Locations:
city: Narita
country: Japan
facility: International university health and welfare Narita hospital
Study officials:
affiliation: International university of health and welfare Narita hospital
name: Takaomi Kessoku, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06715917: Multicentre GMK UNI Anatomical Cementless Study - FR
Official title: PROSPECTIVE, MULTICENTRE POST-MARKETING SURVEILLANCE STUDY to ASSESS PERFORMANCE of the GMK UNI ANATOMICAL CEMENTLESS IMPLANT
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis of the Knee
Avascular Necrosis of the Femoral Condyle
Revision Surgery
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion/exclusion criteria to take part to the current clinical study will be invited to participate before the surgery.

Brief summary: Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
* Patient's age between 18 and 75 years old;
* Patients must be willing to comply with the pre and postoperative evaluation schedule.

Exclusion Criteria:

* Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
* Any patient who cannot or will not provide informed consent for participation in the study;
* Patients who need a revision surgery
* Patients unable to understand and take action;
* Any case not described in the inclusion criteria;
* Patients aged under 18 years;
* Patients aged over 75 years;

Primary outcomes:
measure: New Knee Society Score (KSS)
timeFrame: Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
Secondary outcomes:
measure: Kujala Score
timeFrame: 3 months, 1, 2, 3, 5, 7 and 10 years
measure: Survival of the implant
timeFrame: 3 months, 1, 2, 3, 5, 7 and 10 years
measure: Safety of the implant
timeFrame: Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: Clinique Saint Vincent de Paul
city: Caen
country: France
facility: Polyclinique du Parc
city: La Rochelle
country: France
facility: Clinique du Mail
city: Saint-Étienne
country: France
facility: Centre Orthéo
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
Study officials:
References:
Clinical trial NCT04791917: Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
Official title: Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Research Society on Alcohol
First posted: 2021-03-10
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years;
* English-speaking
* Self-identify as White/Caucasian or Black/African American
* Own a smartphone with cellular/data plan
* Regularly co-use alcohol and smoked marijuana as indicated by scores of ≥3 on item 1 of the CUDIT-R and AUDIT.
* Willing and able to give informed consent

Exclusion Criteria:

* Participation in biceps-specific conditioning program in the past 6 months\*
* Self-reported wrist/hand, elbow, or shoulder pain the past 3 months
* Chronic medical condition that may affect pain perception (e.g. diabetes, fibromyalgia, headaches)
* Self-reported kidney dysfunction, muscle damage, or major psychiatric disorder
* Medical marijuana prescription
* Consumption of marijuana using only non-inhalational methods (e.g. edibles, tinctures, or cannabidiol oil)
* Score of ≥ 10 on Patient Health Questionnaire-9 (moderate depression)
* Women who are pregnant, trying to become pregnant, or breastfeeding

Primary outcomes:
measure: Alcohol Demand: Breakpoint
timeFrame: 48 hours after exercise
measure: Alcohol Demand: Omax
timeFrame: 48 hours after exercise
measure: Alcohol Demand: Pmax
timeFrame: 48 hours after exercise
measure: Alcohol Demand: Essential Value
timeFrame: 48 hours after exercise
measure: Cannabis Demand: Intensity
timeFrame: 48 hours after exercise
measure: Cannabis Demand: Breakpoint
timeFrame: 48 hours after exercise
measure: Cannabis Demand: Omax
timeFrame: 48 hours after exercise
measure: Cannabis Demand: Pmax
timeFrame: 48 hours after exercise
measure: Cannabis Demand: Essential Value
timeFrame: 48 hours after exercise
measure: Alcohol Demand: Intensity
timeFrame: 48 hours after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Center for Pain Research and Behavioral Health
state: Florida
Study officials:
affiliation: University of Florida
name: Jeff Boissoneault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621517: Bupropion and Restless Legs Syndrome
Official title: Bupropion and Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Restless Legs Syndrome
Keywords: Restless Legs Syndrome
Bupropion
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 60
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: The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).

Detailed description: Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Restless Legs Syndrome
* Severity Scale score 15 or higher

Exclusion Criteria:

* History of seizures
* History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day
* Suicidal thoughts/ideations
* Inability to return for follow up appointments at 3 and 6 weeks
* Lack of access to telephone
* Eating disorder
* Age less than 18
* Pregnancy
* Unwillingness or inability to discontinue any RLS medications

Primary outcomes:
measure: Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
timeFrame: Baseline, three weeks, and six weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: three weeks and six weeks
measure: Ordinal Scale (i.e., 1-8) of Symptom Severity
timeFrame: three weeks and six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
References:
Clinical trial NCT05591417: Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries
Official title: Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.

Detailed description: High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.

Eligibility criteria: Inclusion Criteria:

* Female patients scheduled for Modified Radical Mastectomy MRM
* Physical status ASA II, III.
* Age (18-65) years
* Body mass index (BMI): (20-35) kg/m2.

Exclusion Criteria:

* Patient refusal.
* Age \<18 years or \>65 years.
* BMI \<20 kg/m2 and \>35 kg/m2.
* Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).

Primary outcomes:
measure: Total morphine consumption in the first 24 hours postoperatively.
timeFrame: First 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00314717: The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
Official title: The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gestational Diabetes
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2006-04-14
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if a low glycemic index diet will reduce blood sugar levels in pregnant women with high blood sugar levels.

Detailed description: Women with gestational hyperglycemia, including women with gestational diabetes and impaired glucose tolerance of pregnancy, consuming a low glycemic index (GI) diet will experience better blood glucose control thereby decreasing the risk associated complication(s).

Eligibility criteria: Inclusion Criteria:

* women with gestational hyperglycemia
* age between 18 and 45 inclusive
* willing and able to comply with protocol

Exclusion Criteria:

* \<18 or \>45 years of age
* other chronic or acute illness which affects carbohydrate metabolism
* known multiple pregnancy
* \>34 weeks gestation
* language barrier (no translator available)

Primary outcomes:
measure: Fasting serum glucose
timeFrame: Baseline and 4 weeks
measure: A1c
timeFrame: Baseline and 4 weeks
measure: Self-blood-glucose-monitoring results
timeFrame: daily until delivery
Secondary outcomes:
measure: maternal weight gain throughout pregnancy
timeFrame: weekly
measure: number of individuals who receive insulin treatment while participating in the study
timeFrame: duration of pregnancy
measure: latency to insulin requirement/ gestational age when prescribed insulin
timeFrame: duration of pregnancy
measure: dosage and frequency of insulin
timeFrame: duration of pregnancy
measure: ultrasound measurements (if available)
timeFrame: according to clinical practice
measure: fasting lipids
timeFrame: Baseline and 4 weeks
measure: fasting c-reactive protein
timeFrame: Baseline and 4 weeks
measure: infant birth weight
timeFrame: at birth
measure: infant blood glucose
timeFrame: at birth
measure: infant plasma calcium
timeFrame: at birth
measure: infant bilirubin at birth obtained via heel prick
timeFrame: at birth
measure: birth complications
timeFrame: at birth
measure: perceptions of educational materials
measure: perceptions of diet treatments
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20.
Clinical trial NCT03984617: Impact of Football Matches on the Emergency Admissions of a Level III Maternity During EURO 2016
Official title: Impact of Football Matches on the Emergency Admissions of a Level III Maternity During EURO 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 1114
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to emergencies are informed of the protocol and a questionnaire is provided by the care team.

Brief summary: Attendances at an emergency department (ED) are often considered to depend on different factors such as moonlight, welfare checks, weather, and major sporting events. Data regarding effects of large sporting events on the workload of ED often assessed decreased patient volume, especially male use. Currently, no data are available on the effect of major televised sporting events on obstetrical visits. The aim of this study is to examine whether televised soccer games from a major sporting tournament, (Euro 2016) influence the level of attendance at an obstetrical ED and could have implications for women's welfare.

In the summer of 2016, France hosted the largest European sporting event of the year 2016: the European Football Championships (Euro 2016). A total of 51 games were played over a month, bringing together the biggest European teams. An observational, retrospective study is conducted during this period on the number of emergency visits in a French tertiary Maternity hospital (Maternity of Nancy).


Eligibility criteria: Inclusion Criteria:

All female patients admitted urgently to the Regional Maternity Hospital between June 10 and July 10, 2016

Exclusion Criteria:

* refusal of the patient
* information and understanding impossible

Primary outcomes:
measure: Overall number of maternity emergencies admissions during EURO 2016 (10June-10July)
timeFrame: At the end of EURO 2016 on 10th July 2016
Secondary outcomes:
measure: Number of daily admissions and per 2 hours time slot every day from June 10th to July 10th
timeFrame: At the end of EURO 2016 on 10th July 2016
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02971917: A Clinical Study of TRUVIEW ART™(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph
Official title: A Clinical Study of TRUVIEW ART(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Diseases
Keywords: Chest radiography
Image improvements
Image Reconstruction
Preprocessing
MTF
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To validate the following theory: "With TRUVIEW ART™ applied a detector's quantitative performance index, MTF(Modulation Transfer Function), is increased 20% or more". This is to examine the effect of the increased MTF index, whether it influences or not the interpreter's preference

Detailed description: Background of Study :

DRTECH Corp. has developed and applied for patenting the unique technology of TRUVIEW ART™. TRUVIEW ART™ is advanced image reconstruction technology that restores image quality from the side effects of scattering signals in indirect type scintillator detectors. It is an advanced image pre-processing technology that constructs signal scattering models (PSF) of indirect type detector scintillators. Image sharpness (MTF) is improved by predicting scattering models and eliminating the scattering signal.

Purpose of Research and Assumption :

Indirect conversion type detectors using scintillators are universal in today's diagnostic imaging area. However, they have a disadvantage of signal scattering compared with direct conversion type detectors. TRUVIEW ART™(Advanced Reconstruction Technology) can restore images from the scattering problems. The purpose of this study is to verify how well it improves the usefulness in clinical diagnostic imaging. Evaluation will measure the improvements in MTF, which is the quantitative performance index of a detector.

Eligibility criteria: Inclusion Criteria:

* Adults of age 20 or higher
* Person who is able to fully understand the clinical research procedures
* Signed up agreement form
* Patient who visits for Chest computed tomography (CT)

Exclusion Criteria:

* Subject is pregnant or suspicious of being pregnant
* Not able or willing to provide Informed Consent, or consent is withdrawn
* Not able to collect all required case information

Primary outcomes:
measure: Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)
timeFrame: Report composed based on analysis of clinical images accumulated over 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Radiology, Seoul National University Hospital
name: Jin Mo Goo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: