louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00053378: A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Official title: A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypocalcemia
Keywords: hypocalcemia, ionized calcium, intensive care
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients


Eligibility criteria: Inclusion Criteria:

* ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.

Exclusion Criteria:

* Serum creatinine greater than 2.5 mg/dL

Primary outcomes:
measure: The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.
Secondary outcomes:
Other outcomes:
Locations:
city: Merced
country: United States
facility: Merced Heart Association
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Hudson
country: United States
facility: Outcomes Research Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital Clinical Research Center
state: Kentucky
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Hopewell
country: United States
facility: Heart Care Associates
state: Virginia
Study officials:
affiliation: Abbott
name: Joel Z Melnick, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04777578: Effects of Dry Needling in Teres Major in Patients With Shoulder Pain
Official title: Effects of Dry Needling in Teres Major in Patients With Shoulder Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of the dry needling technique in teres major muscles on pain, range of motion, strength and extensibility of the posterior part of the tissues of the shoulder in athletes with shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Athletes with Shoulder pain
* Glenohumeral internal rotation deficit
* Presence of active MTrP in the teres major muscle

Exclusion Criteria:

* Previous surgery in the upper limb
* Previous physiotherapy treatments in the shoulder
* Dry needling contraindications
* Previous dry needling experience to mantain the blinding

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Range of motion
timeFrame: Baseline
measure: Range of motion
timeFrame: immediately after the intervention
measure: Strength
timeFrame: Baseline
measure: Strength
timeFrame: immediately after the intervention
measure: Extensibility
timeFrame: Baseline
measure: Extensibility
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Luis Ceballos Laita
Study officials:
References:
Clinical trial NCT01279278: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?
Official title: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Screening
General Practitioner
Fecal Occult Blood Tests
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: Adeca 75
name: Société de Formation Thérapeutique du Généraliste
name: Hotel Dieu Hospital
First posted: 2011-01-19
Enrollment: 2700
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).


Eligibility criteria: Inclusion Criteria:

* Aged : 50 to 74 years.
* Not having ever been invited to participate in colorectal screening.

Exclusion Criteria:

* Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).

Primary outcomes:
measure: Completion of Fecal Occult Blod Test
timeFrame: 7 months
Secondary outcomes:
measure: Measure the impact of co-signing on deadline for completion of the test after the mailing.
timeFrame: 7 months
measure: Compare the proportion of uninterpretable tests.
timeFrame: 7 months
measure: Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications.
timeFrame: 7 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Université Paris Descartes
state: Ile de France
Study officials:
References:
Clinical trial NCT05681078: The Impact of Hearing Loss Severity on Balance Intervention Outcomes
Official title: The Impact of Hearing Loss Severity on Balance Intervention Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Fall
Postural Balance
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn about how hearing loss impacts balance intervention outcomes and risk of falling in older adults. The main questions it aims to answer are:

* How does the evidence-based A Matter of Balance (AMOB) program affect older adults' falls risk and balance-related measures?
* Is the severity of someone's hearing loss related to their balance intervention (AMOB) outcomes?

Participants will:

* Complete a hearing and balance test
* Answer some questions about their background and health history, their thoughts about potential falls and how this impacts them, and their current physical activity level
* Participate in the A Matter of Balance Program, an evidence-based program that includes group discussion, activities, and exercises to reduce fall risk


Eligibility criteria: Inclusion Criteria:

* age of 60 years old or greater
* absence of any major physical or health condition that would prevent participation in the intervention sessions
* English speaking

Exclusion Criteria:

* severe balance disorder diagnosis
* uncorrected severe vision impairment

Primary outcomes:
measure: Change in postural sway from baseline to after completion of AMOB
timeFrame: baseline and within 1 month post training
Secondary outcomes:
measure: Change in balance confidence from baseline to after completion of AMOB
timeFrame: baseline and within 1 month post training
measure: Change in falls risk from baseline to after completion of AMOB
timeFrame: baseline and within 1 month post training
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT02693678: Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception
Official title: Real or Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS) in Skiers, Effect on Knee Joint Proprioception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Proprioception
Doms
Pain
Massage
Diathermy
Lead sponsor: Studi Fisioterapici di Montagna
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences and Arts of Southern Switzerland
First posted: 2016-02-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint . The study aim is to assess the effect of manual massage, diathermy and sham diathermy the proprioception of the knee joint in patients affected by DOMS.

Detailed description: Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint. The study aim is to assess the effect of manual massage, diathermy and sham diathermy on the proprioception of the knee joint in patients affected by DOMS.

Proprioception will be measured with "Technique" an App available on appstore , on the basis of the work on knee proprioception by S M Mir 2008 , and data about pain with numbering pain rating scale (NPRS) and pre-post treatment and global impression of change (PGIC) will be acquired.

Eligibility criteria: Inclusion Criteria:

* Patients with DOMS after a skimountaineering race

Exclusion Criteria:

* Comorbidities, trauma

Primary outcomes:
measure: Knee joint proprioception
timeFrame: 30min post treatment
Secondary outcomes:
measure: Patient global impression of change (partecipants can determine if after receiving the treatment they feel to be improved or not on an nominal level)
timeFrame: 30min post treatment
Other outcomes:
measure: Numeric pain rating scale (NPRS) (1 to 10 scale where 1 is the minor level of pain and 10 is the worst)
timeFrame: 30min post treatment
Locations:
Study officials:
affiliation: Studi Fisioterapici di Montagna
name: Lorenzo Visconti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mir SM, Hadian MR, Talebian S, Nasseri N. Functional assessment of knee joint position sense following anterior cruciate ligament reconstruction. Br J Sports Med. 2008 Apr;42(4):300-3. doi: 10.1136/bjsm.2007.044875.
citation: Visconti L, Capra G, Carta G, Forni C, Janin D. Effect of massage on DOMS in ultramarathon runners: A pilot study. J Bodyw Mov Ther. 2015 Jul;19(3):458-63. doi: 10.1016/j.jbmt.2014.11.008. Epub 2014 Nov 24.
citation: Visconti L, Forni C, Coser R, Trucco M, Magnano E, Capra G. Comparison of the effectiveness of manual massage, long-wave diathermy, and sham long-wave diathermy for the management of delayed-onset muscle soreness: a randomized controlled trial. Arch Physiother. 2020 Jan 15;10:1. doi: 10.1186/s40945-019-0073-4. eCollection 2020.
Clinical trial NCT04550078: The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study
Official title: The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
name: Arla Foods
name: University of Aarhus
name: Innovation Fund Denmark
First posted: 2020-09-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is \>50 years and \<65 years of age by the time of inclusion.
* Subject has been menopausal for 2-5 years.
* Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
* Subject is non-smoking or able not to smoke during clinic visits.
* Subject with no history of osteoporotic fractures.
* Subject is willing and able to provide written informed consent prior to participation.

Exclusion Criteria:

* Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy.
* Subject with vitamin D insufficiency defined as ≤50nmol/l.
* Subject with an osteoporosis diagnosis.
* Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
* Subject with any serious illness e.g. cancer.
* Subject with lactose intolerance.
* Subject with celiac disease.
* Known or suspected abuse of alcohol or recreational drugs.
* Known or suspected hypersensitivity to trial products or related products.
* Subject where it is not possible to obtain sufficient data.

Primary outcomes:
measure: Serum Ionized calcium concentration
timeFrame: 3 months
Secondary outcomes:
measure: Serum calcium concentration
timeFrame: 3 months
measure: Serum phosphate concentration
timeFrame: 3 months
measure: Serum magnesium concentration
timeFrame: 3 months
measure: Serum PTH concentration
timeFrame: 3 months
measure: Urinary calcium concentration
timeFrame: 3 months
measure: Urine phosphate concentration
timeFrame: 3 months
measure: Urine magnesium concentration
timeFrame: 3 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: University of Copenhagen
name: Inge Tetens, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06029478: Understanding Engagement Trends in Chondrosarcoma Clinical Trials
Official title: Understanding Engagement Trends in Chondrosarcoma Clinical Trials: Investigating Participation Patterns Among Chondrosarcoma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chondrosarcoma
Keywords: chondrosarcoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chondrosarcoma who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization.

Brief summary: Taking part in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of chondrosarcoma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chondrosarcoma patients.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Able to comprehend the investigational nature of the protocol and provide informed consent
* Diagnosis of chondrosarcoma

Exclusion Criteria:

* No diagnosis of chondrosarcoma confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of chondrosarcoma patients who decide to enroll in a clinical trial
timeFrame: 3 months
measure: Rate of chondrosarcoma patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Speetjens FM, de Jong Y, Gelderblom H, Bovee JV. Molecular oncogenesis of chondrosarcoma: impact for targeted treatment. Curr Opin Oncol. 2016 Jul;28(4):314-22. doi: 10.1097/CCO.0000000000000300.
citation: Beena D, Kattoor J, Mathews A, P Nair S, M V, T P, N G. Mesenchymal Chondrosarcoma-A Retrospective study. Gulf J Oncolog. 2021 Jan;1(35):54-58.
citation: Thompson LD, Gannon FH. Chondrosarcoma of the larynx: a clinicopathologic study of 111 cases with a review of the literature. Am J Surg Pathol. 2002 Jul;26(7):836-51. doi: 10.1097/00000478-200207000-00002.
Clinical trial NCT00596778: Chest Physiotherapy on Immediate Postoperative in Patients Submitted to High Abdominal Surgery
Official title: Chest Physiotherapy on Immediate Postoperative in Patients Submitted to High Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Surgery
Spirometry
Chest Physiotherapy
Keywords: Physical therapy specialty
Postoperative period. Abdominal surgery
Anesthesia recovery period
Spirometry
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2008-01-17
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the study was to evaluate the benefits of an early intervention of chest physiotherapy during immediate post-operative in patients submitted to elective abdominal surgery.

Detailed description: Thirty-one adults were randomly assigned to control and chest physiotherapy groups. Spirometry, pulse oximetry and anamneses were performed before (pre-operative) and in the second post-operative day. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not. Chest physiotherapy improved oxygen-hemoglobin saturation in elective post-operative abdominal surgeries.

Eligibility criteria: Inclusion Criteria:

* Pre-operative for elective upper abdominal surgery, such as - hernia repair, gall bladder or large bowel removal, exploratory laparotomy, and submitted to general anesthesia or other interventions in abdominal cavity accomplished by conventional laparotomy

Exclusion Criteria:

* Patients with indication of liver transplant or bearers of aneurysm of any arterial segment.
* Patients submitted to video-laparoscopy surgery.

Primary outcomes:
measure: Effective of chest physiotherapy before and after surgery
timeFrame: 3 days (before surgery - second post operative)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005371: Epidemiology of Acute Phase Protein and CHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Atherosclerosis
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality.

Detailed description: BACKGROUND:

The use of stored serum from the MRFIT cohort contributed additional information on how various lipid fractions and other serum constituents interact to produce atherosclerotic disease. The cost of performing such studies on a new cohort would be many times greater.

DESIGN NARRATIVE:

The case-control study evaluated: 1) the relationship between acute phase reactants, albumin, alpha 1 glycoprotein c-reactive protein and sialic acid; 2) oxidized low density lipoprotein cholesterol (LDLC) measured by thiobarbituric acid reactive substances (TBARS), and risk of myocardial infarction or coronary heart disease death; 3) Lp(a); 4) antioxidized vitamin E and carotene. The study was done in one year because of the need to analyze the specimens shortly after they were thawed. The statistical analysis was done in collaboration with University of Minnesota Coordinating Center.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Lewis Kuller
References:
Clinical trial NCT03475771: Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery
Official title: Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Pelvic Fracture
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in GHPSJ orthopedy yard between december 2014 and january 2017

Brief summary: Pelvic fracture are very often treated by surgery ; however there are a high level of thrombotic risk during the surgery (venous thrombo embolic events represent about 10% to 50%.

The aim of our study is to report the number of these events and identify the risk factor associated to these events regarding Greenfield Risk Assessment Profile .


Eligibility criteria: Inclusion Criteria:

* indication to pelvic fracture surgery
* age above 18 years

Exclusion Criteria:

* pelvic fracture without surgery indication.

Primary outcomes:
measure: number of venous thrombo-embolic events
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: BONHOMME Stéphanie, MD
role: PRINCIPAL_INVESTIGATOR
References: