louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03943355: Nonoperative Management Protocol in Patients With Blunt Splenic Injuries
Official title: Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blunt Injuries
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 399
Sex: ALL
Minimum age (years): 17
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective study was performed on adult trauma patients with BSI who were admitted from 2005 to 2016. The patients were divided into before cohort (2005-2010) and after cohort (2011-2016).

Brief summary: This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period in our institution.

Detailed description: The nonoperative management (NOM) protocol with angioembolization (AE) presents a trend in dealing with trauma patients with blunt splenic injury (BSI). This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period.

Eligibility criteria: Inclusion Criteria:

* Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016.

Exclusion Criteria:

* Patients younger than 16 years
* Patients who died in the emergency department

Primary outcomes:
measure: The numbers of associated complications and mortality
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: TSANG-TANG Hsieh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05067855: Effects of Pilates Exercises in Squash Players
Official title: Effects of Pilates Exercises on Service Speed and Agility in Squash Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of Pilates Exercises on service speed and agility in Squash Players

Detailed description: Squash was originated in England in the early 19th, when a group of schoolchildren noticed that punctured balls could be "squashed" against walls in a wider range of shots and it requires more effort from the player. This variation gained popularity, and the first squash courts were made in 1864; and the sport of squash was formally formed. Squash is a racquet sport in which two players compete with a hollow rubber ball on a court surrounded on four sides by walls. The players alternate hitting the ball using racquets. The ball can bounce once on the ground and as many times as the court walls allow. Squash players' main approach is to compel their opponents to go around the entire playing field. If this tactics is successful, the challenger travels a greater distance and puts a higher load on the body.

The purpose of this study is to determine the effectiveness of pilates exercises on service speed and agility in squash players.

Eligibility criteria: Inclusion Criteria:

* Active squash player
* Players playing squash for \> 1 year
* Players engaging in squash ≥ 3 days in a week

Exclusion Criteria:

* History of any injury in past 6 months
* Those players having musculoskeletal, neurological and cardiovascular problems
* Those players who have any medical conditions

Primary outcomes:
measure: Speed Measuring Gun
timeFrame: Six weeks
measure: Badcamp Agility Test
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Sport Complex
state: KPK
Study officials:
affiliation: Riphah International University
name: Aadil Omer, Ph.D.*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452855: Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea
Official title: Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Nausea
Vomiting
Post operative
Propofol remifentanil anaesthesia
Sevoflurane remifentanil anaesthesia
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: Nielsen, Jens OD, M.D.
First posted: 2007-03-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

Detailed description: Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.

Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced.

Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours.

In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.

Eligibility criteria: Inclusion Criteria:

* Females younger than 50 years
* ASA I-II
* Scheduled to gynaecological laparotomies or laparoscopies

Exclusion Criteria:

* Medication known to act anti-emetic
* ASA status greater than II
* Malignant hyperthermia
* Allergy to the drugs used.

Primary outcomes:
measure: Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
measure: Vomiting, incidence in PACU and surgical ward
measure: Total PONV after 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Viborg Hospital
Study officials:
name: Jens Ole Dich JO Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02478814: Protein Requirements In Active Populations
Official title: Evaluation of Protein Requirements in Active, Young Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2015-06-23
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in active, young adult males using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility criteria: Inclusion Criteria:

* Healthy, active, young adult males who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
* A minimum score of 10 on the Beep Test (a measure of aerobic fitness)

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use

Primary outcomes:
measure: 13CO2 (carbon dioxide) excretion (μmol/kg/h)
timeFrame: 4 hours / study day
Secondary outcomes:
measure: 13C-Phenylalanine Oxidation (μmol/kg/h)
timeFrame: 4 hours / study day
Other outcomes:
Locations:
Study officials:
References:
citation: Packer JE, Wooding DJ, Kato H, Courtney-Martin G, Pencharz PB, Moore DR. Variable-Intensity Simulated Team-Sport Exercise Increases Daily Protein Requirements in Active Males. Front Nutr. 2017 Dec 21;4:64. doi: 10.3389/fnut.2017.00064. eCollection 2017.
Clinical trial NCT05149014: Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
Official title: Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Breast Cancer
Lead sponsor: Daiichi Sankyo France
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Unresectable or metastatic HER2+ breast cancer, treated at least once with trastuzumab deruxtecan

Brief summary: Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.

Detailed description: The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.

Eligibility criteria: Inclusion Criteria:

* Male or female adult patient (age ≥ 18 years);
* Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:

  * previously treated by compassionate trastuzumab deruxtecan (ATU group), or
  * previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group);
* Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.

Exclusion Criteria:

- Previous participation in an interventional clinical trial with trastuzumab deruxtecan

Primary outcomes:
measure: Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
timeFrame: 2 years following the start of administration of Trastuzumab deruxtecan
Secondary outcomes:
Other outcomes:
Locations:
city: Coudekerque-Branche
country: France
facility: Clinique des Flandres
Study officials:
References:
Clinical trial NCT01338714: The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function
Official title: The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Dysfunction
Keywords: HBV carrier
HBV DNA title
Chinese Medicine
Liver function
RHD-1
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2011-04-19
Enrollment: 58
Sex: ALL
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: The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective on HBV Carrier With Abnormal Liver Function.

Detailed description: % change HBV DNA title and liver function.

Eligibility criteria: Inclusion Criteria:

* 40 \< GPT \<200 HBV carrier Age: 18-65 yrs old

Exclusion:

Creatinine \>2.0 mg/dL Total bilirubin \> 2.0mg/dL Not suitable patients diagnosis by physician in charge.

Primary outcomes:
measure: the % change of HBV DNA title
timeFrame: 6 weeks
Secondary outcomes:
measure: the % change of GPT
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
References:
citation: Hsu CH, Hwang KC, Chiang YH, Chou P. The mushroom Agaricus blazei Murill extract normalizes liver function in patients with chronic hepatitis B. J Altern Complement Med. 2008 Apr;14(3):299-301. doi: 10.1089/acm.2006.6344.
citation: Chu CJ, Hussain M, Lok AS. Quantitative serum HBV DNA levels during different stages of chronic hepatitis B infection. Hepatology. 2002 Dec;36(6):1408-15. doi: 10.1053/jhep.2002.36949.
citation: Lee CJ, Cheng CH, Li YH, Liu CY, Hsu CH. A Chinese medicine, Kuan-Sin-Yin decoction, improves liver function in hepatitis B virus carriers: a randomized, controlled study. J Altern Complement Med. 2013 Dec;19(12):964-9. doi: 10.1089/acm.2013.0136. Epub 2013 Jul 17.
Clinical trial NCT05883514: The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker
Official title: The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker DDD
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 70
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: SUPPORTIVE_CARE

Brief summary: A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly. Pacemakers are essential when dysrhythmias or conduction defects compromise the electrical system and the heart's hemodynamic response.

The current status aimed to assess the feasibility of motivational interviewing on emotional intelligence, dispositional optimism, and adherence to care practices among patients with permanent pacemaker.

Detailed description: According to the Miller and Rollnick principles, the framework of the motivational interviewing group's sessions was taken from the workbook of the intervention's six motivational interviewing sessions. A researcher recruited participants in groups of 7 patients for six sessions of 60-90 minutes each (two sessions per week). The training sessions covered stress alleviation, appropriate drug usage, quitting smoking, regular physical activity, healthy eating habits, and regular physical activity. Patients in the control group got standard treatment for PPM, including education on proper medication usage, nutrition, exercise, and regular checking.

Eligibility criteria: Inclusion Criteria:

* Patients with permanent cardiac pacemaker implantation aged from 20 up to 65 years old.
* Both sexes (male \& female).
* Able to communicate verbally.
* Free from psychotic disorders.
* Not scheduled for other surgeries.
* Agree to participate in the current study.

Exclusion Criteria:

* Patients with severe mental problems

Primary outcomes:
measure: Adherence with Pacemaker Care Practices
timeFrame: 2 months
measure: Emotional Intelligence
timeFrame: 2 months
measure: Dispositional optimism
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria university
Study officials:
References:
Clinical trial NCT02915614: Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients
Official title: Effects of Pulmonary Rehabilitation on Skeletal Muscle Morphology and Metabolism in PiMM vs. PiZZ COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: alpha-1 antitrypsin deficiency
pulmonary rehabilitation
exercise training
skeletal muscle biopsy
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2016-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al., 2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise capacity compared to PiMM patients. This latter finding was mirrored by an increase of oxidative myofiber type I proportion - that is important for aerobic exercises in daily life - in PiMM but not PiZZ patients.

Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to compare the effects of pulmonary rehabilitation including exercise training on a) specific enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b) the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD patients.


Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease
* phenotype PiMM or PiZZ
* written informed consent

Exclusion Criteria:

* any comorbidities that prevent patients from participating in an exercise Training program
* necessity of anticoagulant therapy
* other genetic variants of alpha-1 antitrypsin than PiMM or PiZZ

Primary outcomes:
measure: Endurance time
timeFrame: 3 weeks
Secondary outcomes:
measure: Myofibre type I Distribution
timeFrame: 3 weeks
measure: Capillary to fibre ratio
timeFrame: 3 weeks
measure: muscle strength
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
Study officials:
affiliation: Department of respiratory medicine, Schoen Klinik Berchtesgadener Land
name: Klaus Kenn, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05604014: Feasibility Study of the My Health Coach App for Adults With FASD
Official title: Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-11-03
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being.


Eligibility criteria: Inclusion Criteria:

* Adult 18 years or older
* Have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
* Have conversational fluency in English
* Own an smartphone

Exclusion Criteria:

* Unable to complete measures or interviews in English
* Do not have a smartphone
* Under 18
* Do not have an FASD or history or prenatal alcohol exposure

Primary outcomes:
measure: Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version
timeFrame: Baseline to 6 Weeks
measure: Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale
timeFrame: Baseline to 6 Weeks
measure: Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale
timeFrame: Baseline to 6 Weeks
measure: Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale
timeFrame: Baseline to 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mt. Hope Family Center
state: New York
Study officials:
References: