louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02196792: Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement
Official title: Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Osteoarthritis
Keywords: Joint Diseases
Musculoskeletal Diseases
radiostereometric analysis
Total hip arthroplasty
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2014-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.


Eligibility criteria: Inclusion Criteria:

* Primary idiopathic arthritis,
* Eligible for uncemented total hip arthroplasty
* 40 to70 years of age,
* Cup size of 54mm and above

Exclusion Criteria:

* Anteversion where non-standard stem can be used,
* Dysplasia (Center-edge angle of Wiberg \< 20°),
* Malignant condition
* Prior radiotherapy
* Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
* Complications during surgery (requiring screws in shell or femoral cerclage)

Primary outcomes:
measure: Mean head penetration from baseline to 5 year follow-up
timeFrame: From baseline to 5 years
Secondary outcomes:
measure: Mean cup migration form baseline to 5 year follow-up
timeFrame: From baseline to 5 years
measure: Mean change in clinical outcome score from baseline to 5 year follow-up
timeFrame: From baseline to 5 years
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Joseph Abdalla Nommesen El-Sahoury
state: Syddanmark
Study officials:
affiliation: OUH Den Ortopædkirurgiske Forskningsenhed
name: Joseph Abdalla N. El-Sahoury, BSc.med
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital, University of Southern Denmark
name: Ming Ding, Professor MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06774092: Prevalence of Anxiety Symptoms Among French General Practitioners
Official title: Prevalence of Anxiety Symptoms Among French General Practitioners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: anxiety
self-employed GPs
prevalence
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GPs, both qualified and established, practicing in France with at least some self-employed practice, who agreed to take part in the study.

Brief summary: Mental health is a major public health issue in the general population, but few studies seem to focus on the mental health of self-employed healthcare professionals, and GPs in particular. As front-line workers who are often called upon to manage complex situations, they are quite likely to suffer from anxiety-depressive symptoms or burnout. Nevertheless, general practice is vast, and there are many different ways of practising and organising it.

Detailed description: The primary objective is to describe the prevalence of clinically significant anxiety symptoms in French self-employed GPs.

The secondary objective is to investigate the factors associated with the presence of clinically significant anxiety symptoms in French self-employed GPs.

Eligibility criteria: Inclusion Criteria:

* general practitioners
* qualified and established
* practicing in France
* with at least some self-employed practice
* agreeing to participate in the study

Exclusion Criteria:

* salaried general practitioners

Primary outcomes:
measure: anxiety
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
References:
Clinical trial NCT06166992: A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body
Official title: Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1291583 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1291583 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-12-12
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 10 days
Secondary outcomes:
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to 10 days
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON
Study officials:
References:
Clinical trial NCT02255292: A Study: Pure CBD as Single-agent for Solid Tumor.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 60
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: Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including the cannabidiol (CBD) which does not posses the psychotropic effects of D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from clinical trials among cancer patients is needed. The aim of the current study is to evaluate the impact of CBD as single treatment among cancer patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed solid cancer
* Approved license for using cannabis (from the ministry of health: Israel)
* Progression of all the available standard therapy / unfit to standard therapy according to oncologist's view
* Measurable disease as determined by RECIST
* Life expectancy of at least 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2
* Aged 18 years old and more

Exclusion Criteria:

* Received cannabis therapy for any indication
* Previous systemic therapy of less than 3 weeks prior to and, if present, any acute toxicity \> grade 1.
* Clinically significant cardiac disease or any history of psychosis
* Pregnancy or breast feeding

Primary outcomes:
measure: Overall Response Rate according to RECIST 1.1
timeFrame: At baseline and at 8 weeks from time of first dose, by CT scans for RECIST 1.1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Hadas Lemberg, PhD
role: STUDY_CHAIR
References:
citation: Mechoulam R, Peters M, Murillo-Rodriguez E, Hanus LO. Cannabidiol--recent advances. Chem Biodivers. 2007 Aug;4(8):1678-92. doi: 10.1002/cbdv.200790147.
Clinical trial NCT01037192: Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Official title: Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin and Soft Tissue Infections
Keywords: outpatient
skin and soft tissue infections
vancomycin intravenous
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2009-12-22
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.


Eligibility criteria: Inclusion Criteria:

* Age 19 to 70 years
* Weight 40 - 80 kg
* Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
* Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
* Subject able to provide informed consent

Exclusion Criteria:

* Known history of allergy to vancomycin
* Pregnancy
* Granulocytopenia (\< 1x109/L)
* Renal impairment (serum creatinine \> 177 µmol/L or eGFR \< 50 mL/min)
* Known history of vestibular disease or hearing loss
* Subjects treated with vancomycin within the previous month
* Subjects who have received more than 24 hours of vancomycin
* Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)

Primary outcomes:
measure: Clinical Efficacy
timeFrame: 5 days
Secondary outcomes:
measure: Microbiological Efficacy
timeFrame: 5 days
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health
name: Anna Yuen, BSc. Pharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60. doi: 10.1093/jac/49.1.155.
Clinical trial NCT01432392: Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease
Official title: A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: gastroesophageal reflux disease
GERD questionnaire
primary care setting
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care setting

Brief summary: The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment

Detailed description: A prospective, observational study to describe symptom control and impact on daily life in patients with gastroesophageal reflux disease (GERD)

Eligibility criteria: Inclusion Criteria:

* Patients known or newly diagnosed with GERD
* Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week
* Patients, currently not treated with a proton pump inhibitor

Exclusion Criteria:

* Patients who have been receiving treatment with non-steroidal antiinflammatory drugs within two weeks prior the inclusion in the study
* Patients with medical history of surgery of the esophagus, stomach or duodenum
* Pregnant or nursing females

Primary outcomes:
measure: Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6
timeFrame: Day 0 to week 4-6
measure: Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6
timeFrame: Day 0 to week 4-6
Secondary outcomes:
measure: To evaluate the correlation between GERD-Q scores and symptom scores
timeFrame: two times
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
Study officials:
References:
Clinical trial NCT00164892: Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial
Official title: Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of Stomach
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

Detailed description: Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which may be upregulated when there are stimuli such as inflammation or hypergastrinaemia. Despite radical surgery, patients with stomach cancer of advanced stages often have a poor prognosis. Reported survival in those with diseases of stage IIIa or above is less than 40%. Methods to improve patients outcome have been explored for decades with little success. In the light of current understanding on the relation between COX-II and stomach cancer, selective COX-II inhibitor may be used as a novel adjuvant therapy after gastrectomy to prevent recurrence of gastric carcinoma. The advantages of COX-II inhibitors are being relatively non-toxic with minimal side effect.

Eligibility criteria: Inclusion Criteria:

* Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.
* Normal renal function

Exclusion Criteria:

* Solid organ metastases
* Poor performance status
* Already on long-term aspirin or NSAID
* Renal or hepatic dysfunction
* Bleeding disorder
* Hypersensitive to COX-II inhibitors/aspirin/NSAID
* No history of myocardial infarct or stoke

Primary outcomes:
measure: Recurrence free survival and the quality of life score within the two years of study period
Secondary outcomes:
measure: Overall survival in long term
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Combine Gastro-intestinal Cancer Clinic
Study officials:
affiliation: Chinese University of Hong Kong
name: Enders K.W. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03461692: A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China
Official title: A Study of 100 Thousand Cases of Pediatric Patients of Clinical Safety Monitoring and Characteristic Observation and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Respiratory Tract Infection
Acute Tracheobronchitis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Nanjing Medical University
name: Hunan University of Traditional Chinese Medicine
name: Qilu Children's Hospital of Shandong University
name: Zhengzhou Children's Hospital, China
First posted: 2018-03-12
Enrollment: 100000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim population for observation of clinical characteristics and adverse reactionsis who using Reduning injection from February 2018 to December 2018.

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in February 2018.

The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed description: In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.

Eligibility criteria: Inclusion Criteria:

Patients aged 14 and below using Reduning injection from February 2018 to December 2018.

Exclusion Criteria:

None

Primary outcomes:
measure: Incidence of Adverse Drug Reaction
timeFrame: 3 days
Secondary outcomes:
measure: The Ratio of Body Temperature to Normal
timeFrame: 3 days
measure: The Ratio of WBC to Normal
timeFrame: 3 days
measure: The Ratio of The Antibiotic Used
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942992: Implementing Resistance Exercise to Reduce Frailty for Older Adult
Official title: Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 126
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.


Eligibility criteria: Inclusion criteria for Home Care Aides:

- Employees of Help at Home, with one eligible client

Inclusion criteria for clients:

* aged 65+ years
* receive HCA services two or more days per week
* English-speaking
* not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
* Telephone Interview for Cognitive Status score \> 26

Exclusion criteria for HCAs:

- no clients who enroll in the study

Exclusion criteria for clients:

* legally blind, no voluntary extremity movement
* physician does not provide clearance for participation
* classified as non-frail based on the SHARE-FI frailty testing
* Telephone Cognitive Status score \< 25.

Primary outcomes:
measure: Number of participants with frailty or pre-frailty as assessed by the SHARE-FI
timeFrame: 26 weeks
Secondary outcomes:
measure: Scores of self-reported overall health as measured by the PROMIS-global health
timeFrame: 26 weeks
measure: Quadriceps muscle strength as assessed by the 30 second chair rise test
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
state: Illinois
Study officials:
References:
citation: Danilovich MK, Diaz L, Ciolinio JD, Corcos DM. Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads. Contemp Clin Trials Commun. 2017 May 12;7:28-32. doi: 10.1016/j.conctc.2017.05.006. eCollection 2017 Sep.