louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04789265: Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
Official title: Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, it was planned to investigate the effectiveness of instrument-assisted soft tissue mobilisation (IASTM) in patients with chronic neck pain. Forty eight individuals with chronic neck pain between the ages of 18-70 were included in the study. Individuals were randomly divided into two groups as Combined Therapy (CT) (n = 24) and Exercise Therapy (ET) (n = 24) groups. All exercises were applied to the participants for 4 weeks, 3 times a week, by an experienced physiotherapist for 5 years under supervision. ET which included stretching and strengthening exercises involving the neck, shoulder and around the scapula muscles applied according to the tolerance of the individuals and targeted to be most beneficial in daily life activities.

CT in addition to the ET applied 3 times a week for 4 weeks, the participants received a total of 8 sessions of IASTM on the days they came to the treatment twice a week, before the ET. As soon as the participants came to the session, IASTM was applied first. Following the IASTM application, ET was applied in the same protocol and under the same therapist supervise with the ET group.

Before and after treatment, deep neck flexor muscle endurance (DNFME), pain severity with Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI), functional status with Neck Disability Index (NDI), quality of life with Nottingham Health Profile (NHP) treatment and treatment satisfaction was evaluated.


Eligibility criteria: Inclusion Criteria, Exclusion Criteria:

Individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included.

Individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.

Primary outcomes:
measure: Neck Flexor Muscle Endurance
timeFrame: baseline to 4 weeks after
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: baseline to 4 weeks after
measure: Neck Disability İndex
timeFrame: baseline to 4 weeks after
measure: Visual Analog Scale
timeFrame: baseline to 4 weeks after
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Aysegul Bostan
state: Beykoz
city: Istanbul
country: Turkey
facility: Aysegul Bostan
state: Beykoz
Study officials:
References:
Clinical trial NCT05584865: Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique
Official title: The Clinical Outcome of Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Occluar Prosthesis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different techniques of fabricating conventional custom-made ocular prosthesis were described. Traditional methods of custom fabricated ocular prosthesis had some limitations and take a long time, facial scanning and computed tomography will facilitate the full digital ocular prosthesis fabrication. Full digital ocular prosthesis is an innovated new technique to produce more accurate \& more esthetic ocular prosthesis with less time consumed, however very few articles are available comparing between the full digital technique \& the conventional one in manufacturing ocular prosthesis.


Eligibility criteria: Inclusion Criteria:

* Have enough ocular bed to accommodate the ocular prosthesis.
* At least 3 months after surgery to allow complete healing of the socket.

Exclusion Criteria:

* Patients under steroid therapy or those under radio or chemotherapy.
* Patients having eye lid deformity.
* History of psychological disorder.
* systemic disease.
* eye infection.

Primary outcomes:
measure: Motility of ocular prosthesis
timeFrame: Time of insertion
measure: Change in patient satisfaction
timeFrame: Time of insertion and 3 months
measure: change in microbial analysis
timeFrame: Time of insertion and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04217265: Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
Official title: Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Missed Abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-03
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.

Detailed description: According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

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.

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.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Primary outcomes:
measure: complete abortion rate
timeFrame: 9 hours
measure: time from induction to abortion
timeFrame: 9 hours
Secondary outcomes:
measure: Need for surgical evacuation of the products of conception
timeFrame: 9 hours
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557465: Mechanical Alternans Study
Official title: Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Heart Failure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with structural heart disease, ischemic or non-ischemic cardiomyopahty

Brief summary: The purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to predict progression of heart failure and death.


Eligibility criteria: Inclusion Criteria:

* structural heart disease
* ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

* pregnancy
* age \< 18 years old

Primary outcomes:
measure: sudden arrhythmic death
timeFrame: 5 years
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: 5 years
measure: all-cause death
timeFrame: 5 years
measure: appropriate ICD therapies
timeFrame: 5 years
measure: composite heart failure endpoint
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
References:
citation: Kim R, Cingolani O, Wittstein I, McLean R, Han L, Cheng K, Robinson E, Brinker J, Schulman SS, Berger RD, Henrikson CA, Tereshchenko LG. Mechanical alternans is associated with mortality in acute hospitalized heart failure: prospective mechanical alternans study (MAS). Circ Arrhythm Electrophysiol. 2014 Apr;7(2):259-66. doi: 10.1161/CIRCEP.113.000958. Epub 2014 Mar 1.
Clinical trial NCT05157165: Convalescent Plasma in Hospitalized COVID-19 Patients
Official title: Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Lead sponsor: Azienda Socio Sanitaria Territoriale di Mantova
Sponsor class: OTHER
First posted: 2021-12-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The study assesses the efficacy and safety of administration of hyperimmune plasma in hospitalized COVID-19 patients. Efficacy was measured as 28-day mortality following convalescent plasma transfusion. Safety was measured as the rate of adverse reactions. to plasma infusion.

Detailed description: Inclusion criteria:

Adult inpatients with a severe form of COVID-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (RR) \> 30 breaths/min; 2) oxygen saturation (SpO2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 200 mmHg, 4) radiological picture and/or chest CT scan showing signs of interstitial disease and/or rapid progression of lung involvement.

Primary outcome:

Overall mortality at 28 days after hospitalization

Secondary outcome:

Adverse reaction to plasma transfusion.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted for severe COVID-19

Exclusion Criteria:

* \< 18 years
* participation in any other clinical trial of an experimental treatment for COVID-19

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03810365: Brief Behavioral Treatment for Insomnia in Cancer Survivors
Official title: Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Cancer Survivors
Brief Behavioral Treatment
Older Adults
Attention Control
Intervention
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Roswell Park Cancer Institute
name: National Institute of Nursing Research (NINR)
First posted: 2019-01-18
Enrollment: 132
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 purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

Detailed description: A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).

Eligibility criteria: Inclusion Criteria:

* \> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
* chronic insomnia

Exclusion Criteria:

* Other preexisting sleep disorders except those with OSA stable on CPAP
* Unstable medical illnesses

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: University at Buffalo, School of Nursing
name: Suzanne S. Dickerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2022 Nov;122:106939. doi: 10.1016/j.cct.2022.106939. Epub 2022 Sep 28.
Clinical trial NCT00273065: Local Anesthetic Properties of Neosaxitoxin
Official title: Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Local Anesthetic
Neosaxitoxin
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans

Detailed description: Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial

Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.

Eligibility criteria: Inclusion Criteria:

* Healthy males with the abilities to understand and respond the tests to perform

Exclusion Criteria:

* Use of any oral analgesics at least ten days before the study
* Drugs abuse history
* Showing at the clinical examination any signal of psychiatric disorder

Primary outcomes:
measure: Neural blockade of five parameters:
measure: sensory threshold for warm
measure: sensory threshold for cold
measure: pain thresholds for heat
measure: pain thresholds for cold
measure: mechanical touch perception threshold
measure: Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections
Secondary outcomes:
measure: Pain on injection (VAS Score 0-10)
measure: Blood sample at 1 hour
measure: Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Henry Mayer Center, Hospital Clínico Universidad de Chile
Study officials:
affiliation: University of Chile
name: Alberto Rodriguez-Navarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Chile
name: Nestor Lagos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Navarro AJ, Lagos N, Lagos M, Braghetto I, Csendes A, Hamilton J, Figueroa C, Truan D, Garcia C, Rojas A, Iglesias V, Brunet L, Alvarez F. Neosaxitoxin as a local anesthetic: preliminary observations from a first human trial. Anesthesiology. 2007 Feb;106(2):339-45. doi: 10.1097/00000542-200702000-00023.
Clinical trial NCT00332865: Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
Official title: Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: Head and neck cancer
Radiotherapy
Dysphagia
Exercise
Deglutition
Randomized controlled trial
Quality of life
Tube feeding
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H\&N35 questionnaire. Weight loss, duration of tube feeding.


Eligibility criteria: Inclusion Criteria:

* Head and neck cancer
* Planned curative radiotherapy
* Planned irradiation of level II+III lymph nodes \>46 Gy
* \>=18 y
* Speaks and reads Danish
* No previous Surgery to the head and neck area except biopsies

Exclusion Criteria:

-

Primary outcomes:
measure: Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing
timeFrame: 2 mths
Secondary outcomes:
measure: Weight
timeFrame: 2 mths
measure: Duration of tube feeding
timeFrame: 2 mths
measure: Swallowing scale of EORTC HN 35
timeFrame: 2 mths
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Kenneth Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201565: Association Between Peripheral Artery Stiffness and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriosclerosis
Keywords: pulse wave velocity
cardiovascular disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Arterial pulse wave velocity (PWV) is strongly correlated with atherosclerosis, and the PWV of carotid or femoral artery could predict the severity of arterial atherosclerosis. Because the measurement of PWV is noninvasive, it would serve as a good clinical and screen marker to evaluate the extent of atherosclerosis. The study uses self-made PWV measurement device to investigate the correlation of the PWV in the high cardiovascular risk population, and compare it with normal population.


Eligibility criteria: Inclusion Criteria:

* Patients with a high risk for cardiovascular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Natinal Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Juey Jen Hwang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058365: Effects of Mindfulness Training on the Psychological Well-being of Preschoolers
Official title: Effects of Mindfulness Training on the Psychological Well-being of Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness-based Intervention for Preschoolers
Keywords: mindfulness, psychological well-being of preschoolers
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 18
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is a randomized controlled trial to evaluate the effectiveness of a mindfulness course on the psychological well-being of preschoolers (i.e., attention and impulsivity, prosocial behavior, empathy, emotion regulation and conduct). Participants will be randomized to either intervention (dots Curriculum) or wait-list control condition. Participants will complete a computerized task and they will be interviewed to complete a scenario test before (baseline) and after the intervention. The parents and class teacher will also be invited to complete a survey at baseline and after the intervention.


Eligibility criteria: * Aged 3-6 years
* Studying in pre-school settings

Primary outcomes:
measure: Attention and Impulsivity
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Empathy
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Prosocial Behavior
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Parent-reported Attention
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Parent-reported Emotion Regulation
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Parent-reported Prosocial Behavior
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Parent-reported Conduct
timeFrame: baseline, immediately after intervention at Week 14
measure: Teacher-reported Attention
timeFrame: Baseline, Immediately after intervention at Week 14
measure: Teacher-reported Emotion Regulation
timeFrame: baseline, immediately after intervention at Week 14
measure: Teacher-reported Prosocial Behavior
timeFrame: baseline, immediately after intervention at Week 14
measure: Teacher-reported Conduct
timeFrame: baseline, immediately after intervention at Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Jockey Club "Peace and Awareness" Mindfulness Culture in Schools Initiative, Faculty of Social Sciences, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Shui-fong Lam
role: PRINCIPAL_INVESTIGATOR
References: