louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03269539: Assessment of Siemens' GoBrain and DotBrain Software
Official title: Assessment of Siemens' GoBrain and DotBrain Software
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred for MRI with History of Headaches

Brief summary: Our main approach in this research is to collect MR data using both a "Routine" and "Fast" brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to determine if the "Fast" protocol can collect data in less time without compromising patient care.


Eligibility criteria: Inclusion Criteria:

* Patients referred for MRI with History of Headaches

Exclusion Criteria:

* Patient does not meet MRI safety criteria
* Patient has known Brain Pathology

Primary outcomes:
measure: Assessment of Siemens' GoBrain and DotBrain Software
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04361539: Shoulder Muscle Imbalance as a Risk for Shoulder Injury in Elite Adolescent Badminton Players
Official title: Shoulder Muscle Imbalance as a Risk for Shoulder Injury in Elite Adolescent Badminton Players : a Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sport Injury
Shoulder Injuries
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population was all the elite adolescent badminton players from a high-level club

Brief summary: Background: To assess the impact of pre-season clinical measures and rotator muscles strength on the risk of significant shoulder injury (SSI) in elite adolescent badminton players Design: Prospective cohort study Participants: Nine elite adolescents badminton players were included and followed from September 2018 to May 2019.

Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Isokinetic internal and external rotator shoulder muscles strength was tested at 60, 120 and 240°/s. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an experienced sport physician.


Eligibility criteria: Inclusion Criteria:

* All the elite adolescent badminton players from a high-level club.

Exclusion Criteria:

* Players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery

Primary outcomes:
measure: Change from Baseline Isokinetic strength testing (peak torques) at 8 months
timeFrame: Two evaluations, one preseason (september 2018) and one postseason (may 2019) visits
measure: Change from Baseline Isokinetic strength testing (ratios) at 8 months
timeFrame: Two evaluations, one preseason (september 2018) and one postseason (may 2019) visits
measure: Clinical measurements, ROM
timeFrame: One evaluation, one preseason visit (september 2018)
measure: Clinical measurements TAD
timeFrame: One evaluation, one preseason visit (september 2018)
measure: Significant Shoulder Injury (SSI) collection (number of injury)
timeFrame: During the badminton season, the number (number, n) of injury was recorded from september 2018 to may 2019
measure: Significant Shoulder Injury (SSI) collection (type of injury)
timeFrame: During the badminton season, the type of injury (number, n) was recorded from september 2018 to may 2019
measure: Significant Shoulder Injury (SSI) collection (time lost from participation)
timeFrame: During the badminton season, the time lost from participation was recorded (in days) from september 2018 to may 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
affiliation: CHU Caen Normandy
name: Joffrey DRIGNY, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01990339: Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Official title: Takepron Specified Drug-use Survey "Gastroesophageal Reflux Disease With Dyspepsia Symptoms"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 14965
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroesophageal reflux disease with dyspepsia symptoms

Brief summary: To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms

Detailed description: This is a special drug use surveillance of lansoprazole (Takepron) with a 4-week observational period, designed to evaluate the efficacy in gastroesophageal reflux disease patients with dyspepsia symptoms (planned sample size, 15000).

The dosage regimen is as follows:

* For reflux esophagitis, the usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. For maintenance treatment of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily.
* For non-erosive gastroesophageal reflux disease, the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Patients with heartburn or acid regurgitation at the start of Takepron administration\* , or patients without heartburn and acid regurgitation, but with endoscopic findings classified as Los Angeles grade A-D at the start of Takepron therapy.
2. Patients with symptoms of dyspepsia (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, upper abdominal bloating, nausea/vomiting, or belching) at the start of Takepron administration\* \*These patients must have answered "never, " "sometimes/mild," "often/moderate," or "frequent/severe" on a 4-point scale questionnaire about subjective symptoms.

Exclusion Criteria:

1. Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks before the start of Takepron administration
2. Patients taking antidepressants

Primary outcomes:
measure: Subjective Symptom Improvement Rate
timeFrame: Start of treatment and Week 4
Secondary outcomes:
measure: Frequency of Adverse Events (Adverse Drug Reactions)
timeFrame: 4 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT06207539: Induction of Abortion in the Second Trimester
Official title: Use Of Hyoscine as An Adjuvant Treatment on Shortening the Time of Abortion Induction in Second Trimester: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Abortion, Second Trimester
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.

Detailed description: The study will be conducted on 40 women who will undergo induction of abortion between 13-24 weeks with positive fetal pulsation. They will be randomly assigned to receive either only misoprostol 400 μg under the generic name of misotac tablets produced by Sigma company according to FIGO classification 2019 and a halved dose if the patient has a history of one or two cesarean sections, or misoprostol 400 μg plus intramuscular administration of hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company.

Eligibility criteria: Inclusion Criteria:

1. Abortion between 13-24 weeks with positive fetal pulsation due to congenital fetal malformations, severe preeclampsia, and maternal life-threatening conditions.
2. Women have up to two cesarean sections.

Exclusion Criteria:

1. Abortion between 13-24 weeks with no fetal pulsation
2. Women who have had two or more caesarean sections.
3. Multiple pregnancies
4. Uterine anomalies, such as septate and didelphis uteri.

Primary outcomes:
measure: Efficacy of hyoscine as an adjuvant treatment in second trimester abortion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University
name: Rania G Anwar El-Skaan
role: STUDY_DIRECTOR
References:
citation: Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.
citation: Stephenson ML, Wing DA. A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations. Drug Des Devel Ther. 2015 Apr 22;9:2321-7. doi: 10.2147/DDDT.S64227. eCollection 2015.
Clinical trial NCT01593839: Functioning Disturbance in Chronic Back Pain: Altered Muscle Metabolism
Official title: Functioning Disturbance in Chronic Back Pain: Altered Muscle Metabolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Non-specific Low Back Pian
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2012-05-08
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons referred to Hospital of rehabilitation due to chronic non-specific low back pain

Brief summary: The main objective of this study is to investigate the muscle metabolism in individuals with chronic non-specific low back pain (CNSLBP) to enhance our understanding of chronic back pain.


Eligibility criteria: The NSCBP group:

* At least 6 patients will be included in this study.
* All patients referred to Vestfold Hospital Trust, Kysthospitalet, diagnosed with chronic NSCBP \>3 months duration will be invited to participate in the study. The invitation will be in a written form.

Exclusion Criteria:

* anamnesis of medical or drug abuse,
* surgery on the musculoskeletal system of the trunk,
* known congenital malformation of the spine or scoliosis,
* body mass index \> 27 kg/m2,
* systemic-neurological-degenerative disease,
* history of stroke,
* psychiatric disorder,
* pregnancy and abnormal blood pressure. The subjects will be asked not to use any medications except for paracetamol preparations one week before examination and instructed not to perform any back-straining exercise for 48 h prior to the study, except for ordinary daily working and/or leisure activities.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stavern
country: Norway
facility: Kysthospitalet, Vestfold Hospital Trust
Study officials:
References:
Clinical trial NCT01690039: Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
Official title: Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acidosis, Renal Tubular
Nephrolithiasis
Vacuolar Proton-Translocating ATPases
Keywords: renal tubular acidosis
V-ATPase
kidney stones
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffered from at least one kidney stone episode.

Brief summary: Purpose

1. To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.
2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.


Eligibility criteria: Inclusion Criteria:

* One or more episodes of nephrolithiasis

Exclusion Criteria:

* Absence of informed consent
* All conditions affecting renal acidification
* Pregnancy
* Nursing

Primary outcomes:
measure: Capability of urinary acidification
timeFrame: Five to six hours
Secondary outcomes:
measure: Polymorphisms in the ATP6V1 gene
timeFrame: 12 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Nephrology and Hypertension, Bern University Hospital
Study officials:
affiliation: Department of Nephrology and Hypertension, Bern University Hospital
name: Daniel Fuster, Attending physician Nephrology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02022839: Role of Lung Ultrasound in Predicting Weaning Outcomes
Official title: B-lines at Lung Ultrasound Predicts Weaning Failure From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Weaning
Ultrasonography
Keywords: mechanical ventilation, weaning
ultrasonography
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanical ventilation patients in a mixed intensive care unit

Brief summary: We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill patients candidates to liberation from mechanical ventilation in predicting weaning outcomes. The analysis will be taken in two times: immediately before and at the and spontaneous breathing trial.


Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation \> 24 hours
* Eligibility to weaning from mechanical ventilation

Exclusion Criteria:

* Tracheostomy

Primary outcomes:
measure: Weaning Failure
timeFrame: Participants will be followed up til weaning success or weaning failure at the end of spontaneous breathing trial. In case of weaning success, then they will be followed for more 48 hours to detect extubation failure.
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande do Sul
Study officials:
affiliation: Hospital Moinhos de Vento, Universidade Federal do Rio Grande do Sul
name: Ana Carolina P Antonio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Cassiano Teixeira, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Marli Knorst, MD, PhD
role: STUDY_CHAIR
References:
citation: Antonio ACP, Teixeira C, Castro PS, Zanardo AP, Gazzana MB, Knorst M. Usefulness of radiological signs of pulmonary congestion in predicting failed spontaneous breathing trials. J Bras Pneumol. 2017 Jul-Aug;43(4):253-258. doi: 10.1590/S1806-37562016000000360.
citation: Antonio AC, Teixeira C, Castro PS, Savi A, Oliveira RP, Gazzana MB, Knorst M. 48-Hour Fluid Balance Does Not Predict a Successful Spontaneous Breathing Trial. Respir Care. 2015 Aug;60(8):1091-6. doi: 10.4187/respcare.03172. Epub 2015 Apr 28.
Clinical trial NCT04185025: Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers
Official title: Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers: A Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CeraVe Moisturising Lotion
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the improvement of CeraVe moisturising lotion on the cuticle moisture of dry skin and barrier repair function.


Eligibility criteria: Inclusion Criteria:

* Those who volunteer to participate in the trial, sign the informed consent, be able to cooperate with follow-up observation, and conduct the trial according to the guidance of the doctor.
* Dry skin subjects with symmetrical distribution of forearm flexion diagnosed by a doctor.
* Those who are 30-80 years old, male or female.
* Those with good compliance who can not use other external drugs during the entire observation period.

Exclusion Criteria:

* Those who do not sign the informed consent.
* Those with the history of allergies to test product and control product ingredients.
* Those who received or are receiving medical or physical therapy for any skin or systemic disease recently (≤3 months)
* Those who have a large amount of exudation in the acute phase or who are infected at the test site.
* Female subjects who are preparing for pregnancy, pregnancy, lactation, or within six months after delivery.
* Those who participate in clinical trials of other moisturizing products or emollients.
* Those who are taking other oral medicines that affect the skin condition.
* Those who the investigator considers unsuitable for other reasons.

Primary outcomes:
measure: Self-assessment from patients
timeFrame: 17 days
Secondary outcomes:
measure: The loss of transdermal water
timeFrame: 0 day, 1 day, 7 days, 14 days, 17 days
measure: Cuticle moisture
timeFrame: 0 day, 1 day, 7 days, 14 days, 17 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT00641225: Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis
Official title: An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Ascending Single Dose
Safety
Pharmacokinetics
Open-label
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Emergent Product Development Seattle LLC
First posted: 2008-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
* Must meet criteria for rheumatoid arthritis with functional class I to III.
* Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age

Exclusion Criteria:

* Any significant health problems other than rheumatoid arthritis.
* Treatment of greater than 10 mg of prednisone per day.
* Treatment with cyclophosphamide.

Primary outcomes:
measure: To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
timeFrame: 12 months
Secondary outcomes:
measure: To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis.
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cohen S, Clowse M, Pardo P, Bhattacharya I, Menon S, Gourley I, Diehl A. Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid Arthritis or Systemic Lupus. Clin Ther. 2016 Jun;38(6):1417-1434.e2. doi: 10.1016/j.clinthera.2016.03.028. Epub 2016 Apr 21.
Clinical trial NCT00538525: Phase II Study of Neoadjuvant Chemotherapy With Doxorubicin Followed by Docetaxel-Cisplatin in Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II study of neoadjuvant chemotherapy with Doxorubicin followed by Docetaxel-Cisplatin in locally advanced breast cancer


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced breast cancer

Exclusion Criteria:

* Patients with metastatic breast cancer

Primary outcomes:
measure: Effectiveness
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KFSH&RC, Riyadh, Saudi Arabia
name: Adnan Ezzat, MD
role: PRINCIPAL_INVESTIGATOR
References: