louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04169035: The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
Official title: The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Woman
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.


Eligibility criteria: Inclusion Criteria:

* The woman is ≥18 years of age
* The woman has a singleton pregnancy
* The pregnancy is ≥28+0 weeks' gestation
* There is a negative antenatal screen for HIV and Hepatitis B

Exclusion Criteria:

* The woman does not fulfil all of the inclusion criteria listed
* There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
* There is a known osteogenesis imperfecta affected pregnancy
* There is suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia)
* There is an intrauterine fetal death in the current pregnancy
* The woman is sensitive to latex
* The woman is currently serving a prison sentence
* The woman lacks capacity to consent
* The woman has a lack of ability to read or understand French as this would preclude successful completion of questionnaires
* The woman has received intramuscular or intravenous opiates (i.e. pethidine or morphine) within the past 6 hours
* The woman is in established labour (≥ 4cm cervical dilatation) without regional analgesia in place

Primary outcomes:
measure: Rate of births successfully assisted with the BD Odon Device
timeFrame: 3 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chu Besancon
Study officials:
References:
Clinical trial NCT04976335: Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair
Official title: Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Tendon Rupture
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures


Eligibility criteria: Inclusion Criteria:

* Cognitively able to converse in English or in native language supported by a certified medical interpreter;
* Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system.

Exclusion Criteria:

* open injury;
* concomitant injury to the contralateral wrist;
* history of flexor tendon repair involving one or both hands or wrists;
* use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively;
* concomitant fracture / injury to the thumb or index finger of one or both hands;
* concomitant carpal tunnel release.

Primary outcomes:
measure: Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
timeFrame: 6 months
measure: Range of Motion: Thumb and Index Finger
timeFrame: 6 months
measure: Range of Motion: Wrist
timeFrame: 6 months
measure: Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion
timeFrame: 6 Months
Secondary outcomes:
measure: Complications
timeFrame: 6 months
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: 6 Months
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: 6 Months
measure: Visual Analog Scale (VAS) pain scores
timeFrame: 6 Months
measure: Subjective Reporting Specific to Tendon Function
timeFrame: 6 Months
measure: Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology
timeFrame: 6 Months
measure: Key Pinch
timeFrame: 6 Months
measure: Three-Jaw Pinch
timeFrame: 6 Months
measure: Grip Strength
timeFrame: 6 Months
measure: Soong Classification
timeFrame: 6 Months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT04115735: His Bundle Recording From Subclavian Vein
Official title: Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Congestive Heart Failure
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing permanent pacemaker implantation identified by the TriHealth Heart Institute Electrophysiologists

Brief summary: His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. This would support the use of stylet driven leads for His bundle pacing.

Detailed description: The purpose of this prospective observational study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years Male or Female Patients undergoing HIS bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath

Exclusion Criteria:

Patients who are unwilling or unable to sign the informed consent Pregnant women

Primary outcomes:
measure: Successful recording of a His bundle potential
timeFrame: From beginning of procedure to the end
Secondary outcomes:
measure: Time necessary to record the HIS bundle
timeFrame: From insertion of the pacing lead until successful measurement of HIS bundle
measure: Pacing threshold
timeFrame: From beginning of procedure to the end of procedure
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TrIHealth
state: Ohio
Study officials:
affiliation: TriHealth Heart Institute
name: Marshall Winner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629935: Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery
Official title: Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall, With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Le Fort; I
Blood Loss
Keywords: orthognthic surgery
le fort I
lateral nasal wall
pterygomaxillary junction
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction.

The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction.

Detailed description: While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy, studies specifically focused on lateral nasal osteotomy are very rare. There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments. In our study, the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane. One group (n=23) will use the routinely employed Nievert osteotome (single guided osteotome), while the other group (n=23) will use a blade osteotome (no guided tip). This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy.

Eligibility criteria: Inclusion Criteria:

* Patients requiring Le Fort I or bimaxillary surgery
* Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)
* Patients without cleft lip or palate
* Patients with no history of midface fractures or craniofacial trauma

Exclusion Criteria:

* Patients with cleft lip and/or palate requiring orthognathic surgery
* Patients with a history of trauma needing orthognathic surgery for malocclusion correction
* Patients who have previously undergone orthognathic surgery and require revision surgery

Primary outcomes:
measure: lateral nasal wall fracture type
timeFrame: 6 months
Secondary outcomes:
measure: pterygomaxillary junction fracture type
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Universty
state: Fatih
Study officials:
References:
Clinical trial NCT04215835: Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
Official title: Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Missed Abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.


Eligibility criteria: Inclusion Criteria:

* Gestational age less than 64 days gestation (\<9 wks).
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 25 kg/m2.
* Missed abortion.
* previous one or more cesarean delivaries

Exclusion Criteria:

* Molar pregnancy.
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.

Primary outcomes:
measure: induction to abortion time
timeFrame: 6 hours
measure: Incidence of complete miscarriage
timeFrame: 6 hours
Secondary outcomes:
measure: Need for surgical evacuation of the products of conception
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01883635: Exercise Intervention for Cancer Survivors and Caregivers
Official title: Dyadic Exercise Intervention for Cancer Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.

Detailed description: This was a pilot feasibility study to refine our methodology before a larger Phase II trial.

Eligibility criteria: Inclusion Criteria for Cancer Survivors:

* Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.
* Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments
* Have a caregiver willing to participate int he study
* Be able to read English
* Be 21 years of age or older
* Give written informed consent

Inclusion Criteria for Caregivers:

* Be nominated by a cancer survivor
* Be able to read English
* Be 21 years of age or older
* Give written informed consent

Exclusion Criteria:

* have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.
* For caregivers, be currently undergoing active treatment for cancer

Primary outcomes:
measure: Psychological Distress
timeFrame: Baseline to post-intervention (6 weeks later)
Secondary outcomes:
measure: Immune Biomarkers
timeFrame: Baseline to post-intervention (6 weeks later)
Other outcomes:
measure: Provision of Social Support
timeFrame: Baseline to post-intervention (6 weeks later)
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Charles Kamen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02533635: Ganoderma Tea on Eczema Patient
Official title: Product Functional Study of Effect A Master Ganoderma Detox Tea on Eczema Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Eczema
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-blind, cross-over pilot study to observe the safety and efficacy of Ganoderma tea on eczema patients.

Detailed description: Objective This study is to conduct a preliminary observation on the effect of A Master Ganoderma Detox Tea in improving eczema symptoms. Because it is a preliminary study, there will not be a placebo control. However, in order to exclude the impact of spontaneous improvement, we will set up a cross over control group. Thus, we want to find out whether there is any difference in taking the tea and without taking the tea.

Research Design This is a randomized, cross-over-control and assessor-blinded clinical trial. Subjects will be divided into groups A and group B. Group A will receive the intervention for 8 weeks, followed by an 8-week period of no intervention. Group B will be observed without having any intervention for 8 weeks, and then receive the intervention for 8 weeks. Randomization will be carried out using a computer program.

Interventions Subjects in the treatment group (A) will take the A Master Ganoderma Detox Tea for 8 weeks. Initially, the dosage is twice a day, one pack (5g) each time, and then increased to three times a day, two packs each time within two weeks. The control group (B) will not receive any study intervention for 8 weeks, followed by similar intervention for 8 weeks.

In case of allergies or severe adverse reactions occur, the subject should stop taking the tea immediately and be excluded from the trial. During the control or intervention period, if necessary, subject may use short-term steroids or other topical medication to relieve the symptoms of eczema.

Eligibility criteria: Inclusion Criteria:

* eczema for 1 year, without other systemic illness.

Exclusion Criteria:

* severe systemic illness,
* oral steroid in the last month

Primary outcomes:
measure: Patient Oriented Eczema Measure
timeFrame: 16 weeks
Secondary outcomes:
measure: Eczema Area and Severity Index
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: School of Chinese Medicine Building
state: Kowloon
Study officials:
affiliation: Hong Kong Baptist University
name: Shi Ping Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06509035: Correlation Between Smartphone Use and Text Neck Posture in Asymptomatic Subjects
Official title: Correlation Between Smartphone Use and Text Neck Posture in Asymptomatic Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smartphone Addiction
Text Neck Posture
Keywords: forward head posture
smart phone use
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty, males and females students, with age 18 - 25 years old recruited from faculty of physical therapy in Misr University for Science and Technology, 6 October, Egypt.

Brief summary: This study will be conducted to investigate the correlation between the number of hours of smartphone usage and severity of text neck posture, cervical ROM, DNF endurance and resting head posture among asymptomatic 18 to 25 years old adults

Detailed description: Smartphone use has increased significantly globally, with 79% of adults aged 18-44 carrying a smartphone constantly. This can cause excessive anterior curves in the neck vertebrae and increase the mechanical load on cervical spine joints. Overuse syndrome, spinal damage, and other side effects can result. This study aims to investigate the correlation between time spent using smartphones and text neck posture and its association with head and neck posture, cervical ROM, and DNF endurance among asymptomatic 18-25-year-olds.

Eligibility criteria: Inclusion Criteria:

1. Individuals who are willing to participate at the time of data collection.
2. Individuals aged 18 - 25 years old.
3. Individuals who use a smartphone to report the duration of weekly usage (at least one year of using a smartphone and minimum duration of smartphone use of ≥1 h per day

Exclusion Criteria:

1. Previous history of an accident or severe injury.
2. Any neurological or cardiovascular problem.
3. Spinal surgery or any disease that prevents the individual from adopting an unsupported orthostatic posture.
4. Congenital cervical problem.
5. Pregnant women.

Primary outcomes:
measure: Assessing the average duration of smartphone screen time
timeFrame: at baseline
Secondary outcomes:
measure: Assessment of head and neck posture
timeFrame: at baseline
measure: Assessment of cervical range of motion
timeFrame: at baseline
measure: Assessment of deep neck flexor endurance
timeFrame: at baseline
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology
Study officials:
References:
Clinical trial NCT02402335: Study of Different Types of Backache in Groups of Patients With Different Diagnoses of Degenerative Diseases
Official title: Study of Different Types of Pains in Groups of Patients With Different Diagnoses of Degenerative Diseases and Their Related Surgeries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ache
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the University Hospital of Bonn who are strongly suffering from backaches that cannot be treated anymore by conservative methods.

Brief summary: The purpose of this study is to examine whether there are relations between different types of pain in groups of patients with different diagnoses of degenerative diseases of the spinal column and their related surgeries.

Detailed description: In the context of this work the pain of different groups of patients should be examined by means of the painDetect Questionnaire, the Roland-Morris disability questionnaire, clinical examinations and different imaging procedures. Two groups of patients are compared with each other. Group one consists of patients with osteoporotic fractures of the vertebra. Group two is formed by patients with osteochondria , spinal disc herniation and nerval compression. Both groups of patients undergo surgery, as they are suffering from pain (e.g. kyphoplasty, nucleotomy, spondylodesis, decompression). In order to differentiate between chronic nociceptive pain and chronic neuropathic pain in these two groups the painDetect questionnaire is used. To examine the severity of disability in the patients' everyday life the Roland-Morris Disability questionnaire is used.

The included patients are examined and seen preoperative, postoperative before discharge from hospital, 6 weeks and 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Backache because of degenerative diseases
* Surgery is necessary

Exclusion Criteria:

-

Primary outcomes:
measure: Backache objectified by the PainDETECT Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital of Bonn
state: NRW
Study officials:
affiliation: University Hospital Bonn, Clinics of Orthopedics and Traumatology
name: Robert Pflugmacher, PD Dr med
role: PRINCIPAL_INVESTIGATOR
References: