louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04875156: The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength
Official title: The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength: Implications for Arthrodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic; Arthrosis
Osteoarthritis Thumb
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: measurement of the joint mobility and the force of the thumb
Primary purpose: TREATMENT

Brief summary: The aim of the study is to measure the position of the metacarpophalangeal joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.

Detailed description: The aim of the study is to measure the position of the metacarpophalangeal (MCP) joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.

The force will be measured in three positions (key-pinch, tripod-pinch and opposition-pinch). Also measured is the degree of flexion of the MCP joint of the thumb. The mobility of the MCP joint of the thumb in maximum flexion and extension will also be measured. A total of about 300 healthy volunteers will be examined, with no history of trauma or disease to tendons or joints of the thumbs and between the ages of 18 and 40. The sponsor of this study is Professor Nadine Hollevoet. Master students of medicine from the faculty of medicine and health sciences will be part of the research team.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 40 years

Exclusion Criteria:

* (previous) pathology of the joints, ligaments or tendons of the thumb

Primary outcomes:
measure: pinch strength of the thumb (in kilograms force)
timeFrame: 10 minutes
measure: the angle of the metacarpophalangeal joint of the thumb (in degrees)
timeFrame: 10 minutes
measure: range of motion of the metacarpophalangeal joint of the thumb (in degrees)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Nadine I Hollevoet, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05948956: Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
Official title: Effects of Combined Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Exercise
Ketone Ester
Keto
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess changes in exercise capacity in people with Parkinson's disease before and after an exercise training program with ketone ester supplementation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's Disease

Exclusion Criteria:

* Any recent changes in EKG, history of myocardial infarction or other cardiac event or other cardiac contraindications to exercise
* Inability to use a step, stand, walk, or use a stationary cycle ergometer
* History of symptoms in exercise that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema or medication side effects
* History of symptomatic cardiovascular or pulmonary disease interfering with exercise
* History of active rheumatoid arthritis
* History of uncontrolled chronic pain syndrome
* Any other history of medical or psychiatric comorbidity precluding safe participation in the project
* Poorly controlled diabetes
* Pregnancy or breastfeeding
* Clinically significant dementia
* Any contraindications to MRI (metal implants, severe claustrophobia, inability to lie still for 1 hour, etc.)

Primary outcomes:
measure: Change in duration of 80 rpm endurance test
timeFrame: After approximately 2-6 weeks of intervention
measure: Change in oxygen uptake (VO2 max)
timeFrame: After approximately 2-6 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Domino's Farms
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chatkaew Pongmala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02458456: Isometric Handgrip Exercise for Blood Pressure Management
Official title: Isometric Handgrip Exercise for Blood Pressure Management. A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of New England, Australia
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to conduct a randomised controlled trial to assess the effect of performing isometric exercise using a handgrip dynamometer on blood pressure.

Detailed description: Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. A randomised controlled study will be conducted with participants who are either pre-hypertensive, blood pressure between 120/80 and 140/90, or on medication to control their blood pressure. Previous studies have utilised a sedentary control so we intend to use a sham group to determine if it can be used as a working control for future studies.

Eligibility criteria: Inclusion Criteria:

* Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.

Exclusion Criteria:

* Younger than 30 years and older than 70 years; those deemed not to have the capacity to voluntarily participate, unable to participate under their doctor's recommendation, or with arthritis or carpal tunnel syndrome who may aggravate their condition with handgrip exercise.

Primary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Compare and contrast changes in blood pressure between the 5% maximum voluntary contraction (MVC) and 30% MVC hypertensive groups
timeFrame: Baseline and 8 weeks
measure: Compare and contrast blood pressure changes between the 30% maximum voluntary contraction (MVC) hypertensive and 30% MVC normotensive groups
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Armidale
country: Australia
facility: University of New England
state: New South Wales
Study officials:
affiliation: University of New England
name: Neil Smart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030.
Clinical trial NCT03870256: Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage
Official title: The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Hemorrhage
Keywords: Postpartum Hemorrhage
vaginal delivery
tranexamic acid
misoprostol
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 135
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a prospective double-blind randomized study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery

Detailed description: Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.

Eligibility criteria: Inclusion Criteria:

* All participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.

Exclusion Criteria:

* were gestational age\<37 weeks,
* genital tract trauma,
* coagulation defect,
* women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
* known hypersensitivity to carbetocin or oxytocin.

Primary outcomes:
measure: the amount of blood loss
timeFrame: 6 hours post delivery
Secondary outcomes:
measure: number of patients loss more than 1000 ml blood
timeFrame: 24 hours post delivery
measure: need of uterotonics
timeFrame: 24 hours post delivery
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: AswanUH
Study officials:
affiliation: Aswan University Hospital
name: hany f allam, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05345756: Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients
Official title: Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 22
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction

Detailed description: Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla

Eligibility criteria: Inclusion Criteria:

* Male or Female Growing Patient ( CVM2-CVM3 )
* Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal \< -0.3mm)
* Erupted upper and lower first permanent molars and permanent incisors
* Reverse overjet up to -4 mm

Exclusion Criteria:

* History of previous orthodontic treatment
* Cleft lip/palate patients
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
* Patients with syndromes

Primary outcomes:
measure: Maxillary skeletal changes
timeFrame: 8 months
Secondary outcomes:
measure: Mandibular skeletal changes
timeFrame: 8 months
measure: Maxillary and Mandibular dental changes
timeFrame: 8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and dental medicine - Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Andrew Demian, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232956: Invasive Pulmonary Aspergillosis and Severe Influenza
Official title: Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspergillosis
Influenza
Critical Illness
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with influenza infection

Brief summary: Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.

Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.


Eligibility criteria: Inclusion Criteria:

* Infection with influenza A or B
* Admission to one of the participating sites

Exclusion Criteria:

* age \< 18
* patients with invasive pulmonary aspergillosis prior to intensive care admission
* consent withdraw

Primary outcomes:
measure: Invasive Pulmonary Aspergillosis
timeFrame: up to 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CHR
city: Nantes
country: France
facility: CHU de NANTES
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT00521456: A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract Extraction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-08-27
Enrollment: 263
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: This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cataract surgery

Exclusion Criteria:

* Uncontrolled ocular disease in cataract surgery eye

Primary outcomes:
measure: Resolution of Post Operative Inflammation
timeFrame: Day 14
Secondary outcomes:
measure: Ocular Pain
timeFrame: Day 1
measure: Mean Pupil Area
timeFrame: Day 0
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.
Clinical trial NCT01968356: In-vivo Efficacy Study of Patient Preoperative Preps
Official title: Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Skin Flora Bacterial Reduction Post-product Application
Keywords: surgical skin prep
CHG
IPA
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2013-10-24
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description: The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Primary outcomes:
measure: Responder Rate
timeFrame: baseline, 10 minute post-product application and 6 hour post-product application
measure: Skin Flora Baseline for Abdominal and Inguinal Regions
timeFrame: Baseline
measure: Skin Flora Recovery Post-treatment
timeFrame: 10 minutes and 6 hours post-treatment
measure: Reduction of Skin Flora Post-treatment
timeFrame: Baseline, 10 minutes and 6 hours
Secondary outcomes:
measure: Safety as Assessed by Skin Irritation Scores
timeFrame: Baseline
measure: Safety as Assessed by Skin Irritation Scores
timeFrame: 10 minutes post-treatment
measure: Safety as Assessed by Skin Irritation Scores
timeFrame: 6 hours post-treatment
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: BioScience Laboratories, Inc.
state: Montana
Study officials:
affiliation: BioScience Laboratories, Inc.
name: Robert R McCormack, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05623956: Proteomics in Small Cell Lung Cancer
Official title: Circulating Metabolites and Tumor-derived Extravesicular Proteins in Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Cell Lung Cancer
Keywords: Proteomics
Biomarkers
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital.

Brief summary: The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.

Detailed description: The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital and blood samples from 50 healthy blood donors.

The blood samples from SCLC patients will be collected before chemotherapy with Carboplatin and Etoposide and after 2 cycles of chemotherapy.

Imaging will be performed at the Dept. of Radiology, Aalborg University Hospital before chemotherapy and after 3 cycles of the treatment.

Eligibility criteria: Inclusion Criteria:

* Written and signed informed consent
* Histopathologically and/or cytologically newly-diagnosed SCLC
* Measurable disease on CT scans
* Eligibility to receive standard chemotherapy consisting of carboplatin and etoposide

Exclusion Criteria:

* Active biopsy-verified second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ
* Prior treatment for any malignant diseases other than non-melanoma skin cancer and cervical carcinoma in situ
* Concomitant anticoagulation treatment (acetylsalicylic acid and clopidogrel are allowed)
* Treatment with any other investigational agent

Primary outcomes:
measure: Identification and validation of protein biomarkers
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region North Jutland
Study officials:
affiliation: Aalborg University Hospital
name: Weronika Szejniuk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: