louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01234545: Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
Official title: A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 35
Sex: MALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital haemophilia and inhibitors to Factor VIII or IX.

Brief summary: This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.


Eligibility criteria: Inclusion Criteria:

* Patients with congenital haemophilia and inhibitors to factor VIII or IX
* Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Clinically relevant coagulation disorders other than congenital haemophilia A or B

Primary outcomes:
measure: Number of bleeds managed at home
timeFrame: Month 8
measure: Number of treatments resulting in the control of bleeding episode
timeFrame: within 9 hours after the first injection of study product
measure: Number of treatments resulting in effective pain relief
timeFrame: within 9 hours after the first injection of study product
Secondary outcomes:
measure: Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home
timeFrame: Month 8
measure: Proportion of patients who used their entire treatment at home
timeFrame: Month 8
Other outcomes:
Locations:
city: Algiers
country: Algeria
city: Casablanca
country: Morocco
city: Muscat
country: Oman
city: Riyadh
country: Saudi Arabia
city: Dubai
country: United Arab Emirates
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04242745: The Effect of Audible Alarm on the Fluid Consumption of the Elderly
Official title: The Effect of an Audible Alarm on the Fluid Consumption of The Elderly Living in a Nursing Home: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Elderly
Keywords: Elderly
fluid consumption
fluid deficiency
nursing home
audible alarm
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Research shows that older people need reminders to increase fluid consumption. The aim of the research was to investigate the effect of an audible alarm on the fluid consumption of old people living in a nursing home. The research was conducted as a single-blind, randomized controlled, prospective experimental study on the pre-test post-test model.

The study was performed between 27 July 2017 and 1 February 2018 at a nursing home in the west of Turkey. Out of 979 in nursing home who conformed to the inclusion criteria of the study, 100 (intervention group (n: 50) and control group (n: 50) were voluntarily included in the sample. The intervention group was given education and a wristwatch which gave an audible alarm to remind them to drink liquid, the control group was given only education. The old people in both groups were monitored before the education, after the education, after the audible alarm and 15 days after the audible alarm every three days on total of 12 days. The amount of liquid that the elderly should drink daily was determined according to Gaspar formula.


Eligibility criteria: Inclusion Criteria:

* Criteria for inclusion in the study were being aged 65 or over, not having a fluid deficiency and living in nursing home.

Exclusion Criteria:

* Exclusion criteria were having an education level of less than primary education
* Being visually or aurally impaired,
* Being bedridden,
* Not being able to take liquids orally, Having health problems such as fever,
* Vomiting, diarrhea or kidney disease causing fluid loss,
* Taking diuretic medication and using more than more than five doses per day,
* Having a diagnosis of a disease such as kidney failure or cardiac insufficiency requiring restriction of fluids, or having a diagnosis of neurological or psychiatric dysfunction, or dementia or Alzheimer's.

Primary outcomes:
measure: Total amount of fluids taken by the elderly
timeFrame: Through study completion, about three years
measure: Fluid deficit of the elderly
timeFrame: Through study completion, about three years
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Katip Çelebi University
Study officials:
affiliation: Izmir Katip Celebi University
name: Perihan ÇETİN, Assistant Professor, PhD
role: STUDY_CHAIR
affiliation: Ege University
name: İsmet EŞER, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03750045: Grip Movement Training for Adults With Fine Motor Limitation
Official title: Proposal for Grip Movement Training for Adults With Fine Motor Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries and Disorders
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to test the system composed by a 3D virtual environment, attached to the Leap Motion, evaluating its effects on the rehabilitation of hand movements in patients with motor alteration.

Detailed description: In order to elaborate the virtual environment, softwares for 3D content creation were used. The virtual environment is formed by four phases, each one having three spheres that are supposed to be inserted, one by one, into a hole located on the scenario floor. Each phase presents a level of difficulty, from pushing the object to performing the grip movement. By the end of each phase, a log file is generated with the time spent on it.

Eligibility criteria: Inclusion Criteria:

* men and women with age equal or higher than 18 years old;
* having clinical diagnosis of neurological pathology;
* presenting fine motor coordination deficit and in grip strength;
* being able to understand instructions in order to perform the tasks of the virtual environment;
* minimum score of 23/24 (from a total of 30) in the Mini-Mental State Examination (MMSE)

Exclusion Criteria:

* Not accepting to participate in this research

Primary outcomes:
measure: Virtual environment
timeFrame: 120 minutes
Secondary outcomes:
measure: Wooden box
timeFrame: Immediately after at the Session 1, 4 and 8.
measure: Dynamometer JAMAR
timeFrame: Immediately after at the Session 1, 4 and 8.
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Terigi Augusto Scardovelli
state: São Paulo
Study officials:
affiliation: University of Mogi das Cruzes
name: Terigi A Scardovelli, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04132245: Family-based Outcome Results
Official title: Famil-based Obesity Prevention Trial in Latino Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: childhood obesity
minorities
diet
physical activity
parents
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many obesity related risk factors are strikingly apparent in minority populations. Mexican-American children have the highest rates of overweight. The goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) Estimate the effectiveness of a 14-week family-based intervention designed to show smaller changes, on average, in BMI appropriate for growth; 3) estimate the effectiveness of a 14-week family-based intervention designed to produce changes in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5 year old Latino children and their parents at post-intervention and Year 1 follow-up.


Eligibility criteria: Inclusion Criteria:

* have received an annual physical
* parent or guardian willing to give consent
* parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child

Exclusion Criteria:

* requires a specialized diet outside of that served by the Chicago Public Schools
* has a chronic physical or behavioral disorder that requyires participant to be under close emdical psychologicagl supervision and routinely absent from the study

Primary outcomes:
measure: Body mass index
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01762345: A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
Official title: A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
SUI
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).


Eligibility criteria: Inclusion Criteria:

* have a ≥ 3 month history of experiencing Stress Urinary Incontinence
* be willing to use the pessary investigational device to control stress incontinence

Exclusion Criteria:

* pregnant, lactating or planning to become pregnant during the study
* within 3 months post partum
* intrauterine device (IUD) placement of less than 6 months
* a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS
* experience difficulty inserting or wearing an intra-vaginal device, including a tampon
* vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months
* has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator
* for any reason, the Investigator decides that the subject should not participate in the study

Primary outcomes:
measure: Change in Pad Weight Gain
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
measure: Change in Stress Urinary Incontinence Episodes
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Secondary outcomes:
measure: Change in Pad Weight Gain
timeFrame: from the 14-day baseline period to the first 7 days of 14-day device usage period
measure: Change in Stress Urinary Incontinence Episodes
timeFrame: from the 14-day baseline period to the first 7 days of 14-day device usage period
measure: Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
timeFrame: baseline and end-of-treatment
Other outcomes:
measure: Percentage of Responders for Pad Weight Gain
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
measure: Percentage of Responders for SUI Episodes
timeFrame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Locations:
city: Chandler
country: United States
facility: Study Center
state: Arizona
Study officials:
affiliation: Radiant Research, Inc.
name: Randall Severance, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03830645: PRP in 2ry Spontaneous Pneumothorax
Official title: Platelet Rich Plasma in Secondary Spontaneous Pneumothorax
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumothorax Spontaneous Secondary
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules


Eligibility criteria: Inclusion Criteria:

* COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion

Exclusion Criteria:

* refusal of participation

Primary outcomes:
measure: Air leak assessment by Cerfolio classification of the air leak by single observer
timeFrame: within 10 days after application of platelet rich plasma
measure: physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay
timeFrame: within 10 days after application of platelet rich plasma
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
timeFrame: one month after removal of intercostal tube
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
timeFrame: two months after removal of intercostal tube
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
timeFrame: three months after removal of intercostal tube
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
timeFrame: six months after removal of intercostal tube
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of medicine Chest Department
state: Asharqia
Study officials:
References:
Clinical trial NCT02896647: 3D Phase Sensitive Inversion Recuperation MRI to Detect and Characterize Multiple Sclerosis Spinal Cord Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for spinal cord MRI exploration for the assessment of a neuraxis inflammatory disease

Brief summary: This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* patients scheduled for spinal cord MRI exploration for the assessment of neuraxis inflammatory diseases

Exclusion Criteria:

* contraindication to MRI
* allergy to contrast media
* patient under legal protection
* no health insurance coverage
* patient's refusal to participate in the study

Primary outcomes:
measure: number of spinal cord lesions
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A De Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Augustin LECLER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04012047: Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Official title: Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Aura
Keywords: Levcromakalim
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To investigate the role of KATP channels in migraine with aura patients.


Eligibility criteria: Inclusion Criteria:

* Migraine with aura patients of both sexes.
* 18-60 years.
* 50-100 kg.

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* Daily consumption of drugs of any kind other than oral contraceptives
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.

Primary outcomes:
measure: Headache
timeFrame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
measure: Migraine
timeFrame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
measure: Aura
timeFrame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Secondary outcomes:
measure: The area under the curve (AUC) for headache
timeFrame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
measure: Family history
timeFrame: After including the patients in the study.
measure: Heart rate
timeFrame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
measure: Blood pressure
timeFrame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish headache center
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina
role: STUDY_DIRECTOR
References:
citation: Al-Karagholi MA, Ghanizada H, Nielsen CAW, Hougaard A, Ashina M. Opening of ATP sensitive potassium channels causes migraine attacks with aura. Brain. 2021 Sep 4;144(8):2322-2332. doi: 10.1093/brain/awab136.
Clinical trial NCT06657547: Urinary Concentration After Salmeterol
Official title: Urinary Concentration After Salmeterol in Well-trained Men and Females
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Urinary concentration
Beta2-adrenergic stimulation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate urine concentration after inhalation of salmeterol. This will be examined following acute physical activity under both normal conditions and heated conditions.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* Age 18-40
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Active smoker currently or within the past 5 years
* Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
* Chronic or acute illness deemed by the responsible study physician to affect the test parameters
* Deviation from the study protocol
* Lean mass index \>21 kg/m²
* Pregnancy
* Smoker
* Blood donation during the past 3 months

Primary outcomes:
measure: Urine concentration
timeFrame: Through study completion, an average on 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT03524547: Endotracheal Tube Shapes for Intubation With Videolaryngoscope
Official title: Comparison of Endotracheal Tube Shapes for Intubation With Videolaryngoscope in Normal Airways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.

Detailed description: Since the intubation using videolaryngoscope does not need straightened oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the successful intubation using the videolaryngoscope.

Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet will be inserted in the endotracheal tubes and will be bent to a specific shape by the assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and ease of intubation wil be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for the surgery under general anesthesia
* Adult patients from 18 years to 65 years
* American society of Anesthesiologist physical status 1,2,3

Exclusion Criteria:

* Previously diagnosed for the difficult intubation
* Pregnancy
* Obesity (Body mass index over 40 g/m\^2)

Primary outcomes:
measure: Time to intubate
timeFrame: 20 minutes after induction started.
Secondary outcomes:
measure: Numbers of intubation attempts
timeFrame: 20 minutes after induction started.
measure: Level of difficulty in intubation
timeFrame: 20 minutes after induction started.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Eunah Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Hyunyoung Lim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: