louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05826262: Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries
Official title: Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current study is aiming to evaluate the diagnostic and therapeutic role of laparoscopy in patients with penetrating anterior abdominal wall trauma as regard the accuracy of diagnosis and efficacy in management and avoidance of unnecessary laparotomy


Eligibility criteria: Inclusion Criteria:

* All patients with penetrating anterior abdominal wall injuries Age will be between 5 - 65 years old

Exclusion Criteria:

* Vitally unstable patients Patients with associated injuries

Primary outcomes:
measure: Morbidity
timeFrame: 1 month
Secondary outcomes:
measure: Mortality
timeFrame: 1 month
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT01395862: Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Official title: Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 1001
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients with asthma who are expected to use fluticasone and salmeterol for long-term.

Brief summary: The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.


Eligibility criteria: Inclusion Criteria:

* Must use fluticasone and salmeterol for the first time
* Must use fluticasone and salmeterol for long-term

Exclusion Criteria:

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis

Primary outcomes:
measure: The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04797962: Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder
Official title: Linkage Navigation to Enhance Initiation and Engagement in Treatment for Opioid Use Disorder to Prevent Overdose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-03-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overarching goal of the study is to develop, pilot, and evaluate an intervention that aims to retain patients who initiate buprenorphine at Denver Health in ongoing treatment for opioid use disorder.

Detailed description: Initiating patients identified with opioid use disorder in hospital settings onto buprenorphine is a relatively new strategy to prevent overdose. While the literature is beginning to amass showing the effectiveness of this strategy for initiating people into treatment, a dearth of data to describe how well people are maintained in treatment remains. The current research project aims to 1) develop an intervention to enhance engagement and retention in treatment for individuals with opioid use disorder who initiate buprenorphine at Denver Health and 2) assess acceptability, feasibility, and initial efficacy of an intervention to enhance engagement and retention in treatment for individuals with opioid disorder compared to usual care.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* inducted onto buprenorphine at Denver Health
* successfully completed an intake visit at Denver Health's Outpatient Behavioral Health Services clinic.

Exclusion Criteria:

* unable to provide informed consent
* unable to provide detailed contact information
* previously enrolled in the current study
* pregnant women will be excluded given that they are a priority treatment population and receive special services

Primary outcomes:
measure: Retention in treatment at 90 days
timeFrame: 90 days from treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Denver Health
name: Alia Al-Tayyib, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05606562: Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment
Official title: Drug-free Without Toothache. A Non-randomized Intervention Study of Free Dental Treatment as a Part of Substance Abuse Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Abuse
Dental Caries
Keywords: Non Randomized Interventional study
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: The main objective of the study is to investigate

1. How many patients will attend and complete dental care if they are offered it for free during the stay at "The department of substance abuse treatment, University Hospital North Norway (UNN) in Narvik".
2. Explore whether a parallel dental treatment in addition to the other treatment at the department has a beneficial effect on the abuse treatment, or whether it can be disruptive to offer dental treatment in combination with admission for drug rehabilitation?

Detailed description: This is a non-randomized clinical study without a control group. Approximately 50 persons admitted to "The department of substance abuse treatment (Russeksjon UNN Narvik)" will be offered free dental service during treatment for drug addiction.

Eligibility criteria: Inclusion Criteria:

People who are hospitalized for drug abuse at Russeksjon UNN Narvik.

Exclusion Criteria:

Non

Primary outcomes:
measure: Dental treatment
timeFrame: Approximately 12 weeks
Secondary outcomes:
measure: Probability measures
timeFrame: Approximately 12 weeks
measure: Aspects of dental treatment
timeFrame: Approximately 12 weeks
Other outcomes:
Locations:
city: Narvik
country: Norway
facility: University Hospital North Norway
state: Nordland
Study officials:
affiliation: University Hospital of North Norway
name: Merethe Kumle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03008291: His Bundle Pacing in Bradycardia and Heart Failure
Official title: His Bundle Pacing in Bradycardia and Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bradycardia
Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the heart clinic at Mayo Clinic in Rochester, Minnesota.

Brief summary: Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block.

The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).


Eligibility criteria: Inclusion Criteria:

HF Group

* Clinically recommended to undergo PM, CRT-P, or CRT-D implantation or HIBP/LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders)
* Any QRS duration
* LVEF ≤ 50%

AV Block/Bradycardia Group

* Recommended to undergo dual chamber pacemaker implantation
* Any AV block or Sinus Bradycardia

Exclusion Criteria:

* Age \< 18 years
* Pregnant

Primary outcomes:
measure: QRS duration as measured by 12-lead ECG
timeFrame: Baseline to 6 months
measure: QRS morphology as measured by 12-lead ECG
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yong-Mei Cha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576862: Extension to Study HMR1964A/3011 in Belgium
Official title: Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.


Eligibility criteria: Inclusion Criteria:

* Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE 901.
* Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism.
* Subjects who are likely to comply with the investigator's instructions.

Exclusion Criteria:

* Evidence of an uncooperative attitude.
* Subject not on adequate contraception, or who is pregnant, or breast feeding.
* Subject unable to understand informed consent.
* Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations.
* Subject becomes pregnant or is planning to become pregnant.

Primary outcomes:
measure: Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)
timeFrame: Mean time interval: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Elke Meyssen
role: STUDY_DIRECTOR
References:
Clinical trial NCT05061862: Cardiac Implantable Electronic Device (CIED) Research Study
Official title: Cardiac Implantable Electronic Device (CIED) Research Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmias, Cardiac
Bradycardia
Tachycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 1000
Sex: ALL
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: Subjects who meet all inclusion criteria and none of the exclusion criteria

Brief summary: The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.

Detailed description: This is a data collection, non-randomized, multi-center study. The study will consist of different cohorts with each cohort being independent from another cohort. Each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. The study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject is willing and able to provide written informed consent.
3. Subject is willing and able to complete the study procedures and visits for the duration of data collection requirements

Exclusion Criteria:

1. Subject is unwilling or unable to comply with study procedures as defined in the protocol.
2. Subject with a medical condition that precludes the patient from participation in the opinion of the investigator.
3. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.

Primary outcomes:
measure: Product Development
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute
state: Florida
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Portland
country: United States
facility: Oregon Health &amp; Science University Hospital
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
Study officials:
References:
Clinical trial NCT00843791: Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Official title: Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: obesity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-02-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

Detailed description: Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80, weight stable for at least 3 months
* At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:

  * fasting plasma glucose level of 100- 125mg/dL or
  * plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load

Exclusion Criteria:

* Actively losing weight
* Smokers
* Alcohol consumption \> 2 drinks/day
* Prescription drug use
* Recreational drug use
* Type 2 Diabetes
* Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone

Primary outcomes:
measure: Total and Active Ghrelin Levels
timeFrame: 0 and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jonathan Q. Purnell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548391: A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biotoxtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 66
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
* History of known hypersensitivity to drugs including HX-1171.

Primary outcomes:
measure: Safety (normal results for safety tests)
timeFrame: 14days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT05534191: Effect of 8 Weeks of Functional and Traditional Off-season Resistance Training on Mobility, Dynamic Balance, Technical Skills, Change of Directions, Linear Sprint, and Jump Performance in U19 Norwegian Soccer Players
Official title: Comparison of Functional and Traditional Strength and Power Training on U19 Soccer Players During Off-season in Norway: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury;Sports
Keywords: Groin
Knee
Ankle
Hamstrings
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2022-09-09
Enrollment: 53
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: To investigate how Norwegian youth soccer players' physical and elementary soccer skills are affected after an 8-week training period using the Functional Football Performance system vs. traditional training methods.


Eligibility criteria: Inclusion Criteria:

* Footballers aged 16 to 20 years old playing in the Norwegian G19 0. Division and Norwegian Tipping Leauge.
* Experience of at least three years playing football.
* Minimum seven out of ten on Tegner´s activity scale.
* The participants must be highly motivated for the project, which will be measured using the - Likard scale. Eight out of ten is expected (The participant will be anonymous in their registration).

Exclusion Criteria:

* Illness or injury within the last three months has kept the participant outside of football.

Primary outcomes:
measure: Active knee extension test
timeFrame: Day 1
measure: Active knee extension test
timeFrame: 2 months
measure: Active dorsi flexion test
timeFrame: Day 1
measure: Active dorsi flexion test
timeFrame: 2 months
measure: Hip internal rotation
timeFrame: Day 1
measure: Hip internal rotation
timeFrame: 2 months
measure: Hip external rotation
timeFrame: Day 1
measure: Hip external rotation
timeFrame: 2 months
measure: Dynamic leap balance test
timeFrame: Day 1
measure: Dynamic leap balance test
timeFrame: 2 months
measure: Loughborough soccer passing test
timeFrame: Day 1
measure: Loughborough soccer passing test
timeFrame: 2 months
measure: Loughborough soccer shooting test
timeFrame: Day 1
measure: Loughborough soccer shooting test
timeFrame: 2 months
measure: S180 sprinting test
timeFrame: Day 1
measure: S180 sprinting test
timeFrame: 2 months
measure: Vertical jumping test
timeFrame: Day 1
measure: Vertical jumping test
timeFrame: 2 months
measure: Agility with ball
timeFrame: Day 1
measure: Agility with ball
timeFrame: 2 months
measure: 10 m and 20 m linear sprint
timeFrame: Day 1
measure: 10 m and 20 m linear sprint
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Steinkjer
country: Norway
facility: SSA Steinkjer
state: Trondelag
Study officials:
References:
Clinical trial NCT04539691: Impacts of Static Magnetic Fields on Dysmenorrhea Pain
Official title: Impacts of Static Magnetic Fields on Dysmenorrhea Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Period Pain
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to determine the effectiveness of a certain type of magnet to reduce period pain

Detailed description: Young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a concentric magnet or a sham that is positioned close to the maximum pain site. The pain score after wearing either the magnet or sham will be recorded.

Eligibility criteria: Inclusion Criteria: Female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 -

Exclusion Criteria:

1. Pain not experienced on almost all menstrual cycles
2. Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease
3. Having a pacemaker or any implanted wires or devices -

Primary outcomes:
measure: Pain score scale of 1-10 / 1 being less pain 10 being more pain
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Davie
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Harvey Mayrovitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: