louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04337151: Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment
Official title: Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MAGEC Rod
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children being treated for early onset scoliosis.

Brief summary: Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium.

Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted in the UK until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible.

At the time of writing, hospitals across the world are facing incredible challenges in dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the virus spreading.

Recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. This wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of FSNs and MDAs.

Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. Additionally, a better understanding of blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of wear and corrosion of the rods. This may help surgeons identify earlier those patients who may develop implant related problems.

Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits.

Previous work from the RNOH involved a similar study investigating patients with titanium hip implants.


Eligibility criteria: Inclusion Criteria:

* Patients that have been treated with, and still have, a MAGEC rod.

Exclusion Criteria:

* Patients that do not have a MAGEC rod implant.

Primary outcomes:
measure: Titanium level
timeFrame: Within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
References:
Clinical trial NCT02878551: Evaluation of the Benefits of a Prehabilitation Program : Pilot Study
Official title: Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Cancer
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-08-25
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: The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Affiliated with a social security system
* Having indicated their non-opposition
* Must undergo a surgical intervention within a period of at least one month after the completion of the initial inclusion assessment and / or chemotherapy and / or radiotherapy

Non-inclusion criteria:

* Refusal of participation
* Pregnant or breastfeeding woman
* Inability to walk or initial physical assessment
* Patient under guardianship or curatorship
* Inability to complete questionnaires

Exclusion criteria:

* Cognitive disorders detected by the geriatric consultation
* Lost
* Death before surgery or chemotherapy or radiotherapy
* Shortened preoperative preparation time (\<18 days)

Primary outcomes:
measure: 6 minutes walk test
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03696251: Master's Nursing Programs in Taiwan
Official title: The Current Situation and Prospects of Master's Nursing Programs in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Master's Nursing Programs
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: the graduates who have graduated from a master's nursing program in Taiwan in recent 3 years.

Brief summary: The purpose of the study: (1) to understand the models of master education in nursing in Taiwan, including goals, curriculum, and clinical hours...etc). (2) to explore the clinical competencies and career development of the graduates of master's nursing program in Taiwan. Methods: Researchers will collect the data of program goals, curriculum, and clinical hours...etc. from the websites of all nursing schools that provide master's education in nursing in Taiwan. A structured self-report questionnaire will be used to collect the data of the clinical competence and career development of the graduates who have graduated from a master's nursing program in Taiwan in recent 3 years. A third of all eligible subjects will be randomly selected and invited to fill out the questionnaire by the schools that they graduated from.


Eligibility criteria: Inclusion Criteria:

1. the graduates who have graduated from a master's nursing program in Taiwan in recent 3 years (2015-2017)
2. The persons who are willing to participate in the study and fill out the questionnaire.

Exclusion Criteria:

1. The person who is unable to read and write Chinese.
2. The person who is unable to fill out the questionnaire by him/her-self

Primary outcomes:
measure: clinical competencies of study subjects
timeFrame: up to 24 weeks
Secondary outcomes:
measure: The questionnaire of employment status
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
References:
Clinical trial NCT02469051: Breath-hold Cardiac Hybrid SPECT/CCTA
Official title: Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-06-11
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: DIAGNOSTIC

Brief summary: This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.


Eligibility criteria: Inclusion Criteria:

* Referral for cardiac hybrid SPECT/CCTA
* Male and female subjects 18 years of age or older
* Written informed consent by the participant after information about the project

Exclusion Criteria:

* Contraindications for coronary CT angiography (including renal failure with a GFR \<30ml/min/1.73m2, allergies to iodinated contrast agents)
* Pregnancy or breast-feeding
* Previous coronary revascularisation
* Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc

Primary outcomes:
measure: Image quality as visually assessed on a Likert scale
timeFrame: 1 day
measure: Number of image artefacts
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Nuclear Medicine, University Hospital Zurich
Study officials:
References:
Clinical trial NCT01903551: Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery
Official title: Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: post-operative pain
loco-regional analgesia
minimally invasive surgery
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
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 evaluate whether loco-regional analgesia reduces post operative pain compared to intravenous analgesia, in patients undergoing cardiac surgery in minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment group) or intravenous analgesia (control group), at the end of the cardiac intervention.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing minithoracotomy for cardiac surgery, \> 18 years old

Exclusion Criteria:

* psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent

Primary outcomes:
measure: ICU lenght of stay and hospital stay
timeFrame: 28 days
Secondary outcomes:
measure: Mechanical ventilation in the post-operative period
timeFrame: 72 hours
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Cardiac Intensive Care Unit
Study officials:
References:
Clinical trial NCT01278251: Functional Review of Distal Biceps Re-Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Biceps Ruptures
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2011-01-17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received primary distal biceps repair by Dr. Schmidt.

Brief summary: This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps successfully restores elbow function.


Eligibility criteria: Inclusion Criteria:

* primary distal biceps repair with endobutton
* at least two years from date of surgery

Exclusion Criteria:

* any ipsilateral wrist, forearm, or elbow condition
* any contraindication to having an MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny Imaging of McCandless
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01362751: Orthostatic Hypotension in Elderly Nursing Home Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthostatic Hypotension
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2011-05-30
Enrollment: 290
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

Brief summary: In this study the investigators aimed

1. to investigate the prevalence of orthostatic hypotension in elderly nursing home residents.
2. to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.


Eligibility criteria: Inclusion Criteria:

* nursing home resident

Exclusion Criteria:

* patients at the palliative department
* life expectancy \< 4 weeks
* patients only temporarily admitted to the nursing home

Primary outcomes:
measure: Orthostatic hypotension
timeFrame: Baseline
measure: Successful rehabilitation
timeFrame: After 5 years
Secondary outcomes:
measure: All-cause and Cardiovascular mortality
timeFrame: Date of death
measure: Quality of life
timeFrame: Measured at baseline and after 1 year
measure: Fall incidents
timeFrame: After 5 years
Other outcomes:
Locations:
city: Hengelo
country: Netherlands
facility: Nursing home TriviumMeulenbeltZorg, location Borsthuis
Study officials:
References:
citation: Hartog LC, Cizmar-Sweelssen M, Knipscheer A, Groenier KH, Kleefstra N, Bilo HJ, van Hateren KJ. The association between orthostatic hypotension, falling and successful rehabilitation in a nursing home population. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):190-6. doi: 10.1016/j.archger.2015.05.005. Epub 2015 May 18.
Clinical trial NCT06205251: Diaphragm Structure and Function in Childhood Cancer Survivors
Official title: Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Childhood Cancer Survivors (2373GCCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Cancer Survivors
Keywords: Inspiratory Muscle Training
Diaphragm
Control of Breathing
Muscle dysfunction
Dyspnea
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors.

Detailed description: During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Eligibility criteria: Inclusion Criteria:

* Completed medical treatment (chemotherapy, chemotherapy/surgery, chemotherapy/radiation or any combination of cancer treatment) for any type of cancer, except for cancer of the central nervous system, at least 1 year ago

Exclusion Criteria:

* History of neuromuscular, cardiac, or pulmonary disease prior to the diagnosis of cancer
* Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
* Dyspnea with minimal activity (4 on the modified Medical Research Council Dyspnea Scale)

Primary outcomes:
measure: Percent completion
timeFrame: 6 weeks
measure: Adherence to treatment protocol
timeFrame: 6 weeks
Secondary outcomes:
measure: Maximal inspiratory pressure (measured in cm H2O)
timeFrame: 6 weeks
measure: Diaphragm thickness (measured in mm)
timeFrame: 6 weeks
measure: Exercise ventilation
timeFrame: 6 weeks
Other outcomes:
measure: 6-minute walk test distance (measured in m)
timeFrame: 6 weeks
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Simon Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01633151: Validation Study for an Unobtrusive Online Sleep Measurement System
Official title: Validation Study for an Unobtrusive Online Sleep Measurement System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea
Restless Legs Syndrome
Sleep Fragmentation
Lead sponsor: Beddit.com Ltd
Sponsor class: INDUSTRY
First posted: 2012-07-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of 20 volunteers - 10 males, 10 females - is recruited so that their ages are distributed evenly between 18 and 80.

Brief summary: The purpose of the study is to determine the precision of an unobtrusive sleep measurement system. The system measures a force sensor signal under the mattress and analyzes sleep quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate, respiration rate, sleep related breathing disorders, and limb movements.


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Finnish-speaking

Primary outcomes:
measure: Precision of sleep measurement
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki Sleep Clinic, Vitalmed Research Centre
Study officials:
affiliation: Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland
name: Markku Partinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06619951: A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
Official title: A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumor
Keywords: Healthy Volunteers
Lead sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will adopt a Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects.


Eligibility criteria: Inclusion Criteria:

* Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
* Able to complete the study in compliance with the protocol;
* Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 6 months after the last dose of study drug;
* Male and female subjects between the ages of 18 and 45 years, inclusive;
* At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index between 19.0-26.0 kg/m2, inclusive;

Exclusion Criteria:

* More than 5 cigarettes per day on average within 3 months prior to screening;
* with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any excipients;
* History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years;
* Donation or loss of a significant volume of blood (\>400 mL) within 3 months prior to screening;

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day1-Day16
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
timeFrame: Day1-Day16
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Affiliated to Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Ling Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02904551: Gingival Augmentation Around Implants During Maintenance
Official title: Free Gingival Grafts for Implants Exhibiting Lack of Keratinized Gingiva: a Prospective Controlled Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failure of Dental Implant Due to Lack of Attached Gingiva
Keywords: prospective study
free gingival graft
keratinized gingiva
dental implant
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline, were assessed at 18 months.

Detailed description: The purpose of this study was to evaluate clinical and radiographic outcomes following free gingival grafts (FGGs) around implants with limited keratinized gingiva (KG) compared to oral prophylaxis without gingival augmentation.

This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months.

There was a significant gain in KG with a reduction in GR in the FGG group compared to controls at 6, 12, and 18 months. The mean PI and GI were significantly lower for the FGG group at 12 and 18 months.

Eligibility criteria: Inclusion Criteria:

1. less than 2 mm KG present on the facial side of implant
2. implant restoration is single unsplinted unit, and has been in function for at least 6 months with an opposing dentition.

Exclusion Criteria:

1. uncontrolled hypertension
2. diabetes mellitus (DM),
3. subjects with a history of a long-term (\>6 months) use of corticosteroid
4. subjects currently taking bisphosphonates, or with a history of taking bisphosphonates regardless of route of administration
5. subjects on medications that cause gingival hyperplasia
6. smokers
7. pregnant women.

Primary outcomes:
measure: Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months
timeFrame: 6, 12, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Advanced General Dentistry at UMB DS
state: Maryland
Study officials:
affiliation: University of Maryland School of Dentistry
name: Se-Lim Oh, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: