louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04384367: Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
Official title: A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 2068
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Detailed description: This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes;
* Aged between 18 and 65 years old;
* Capable and willing to give free and informed informed consent in writing;
* Migraine patients with or without aura, according to the International Headache Society (IHS).

Exclusion Criteria:

* Chronic migraine;
* Headache other than migraine (that is, tension-type headache, sinusitis, etc.).

Primary outcomes:
measure: 2-hour pain-free
timeFrame: 11 weeks
Secondary outcomes:
measure: Most bothersome migraine-associated symptom
timeFrame: 11 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: CEPIC
state: SP
city: São Paulo
country: Brazil
facility: Eurofarma Laboratorios S.A
Study officials:
References:
Clinical trial NCT02482467: Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
Official title: Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cyst
Keywords: ovarian cyst
prenatal diagnosis
puberty
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 105
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

Detailed description: The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.

Eligibility criteria: Inclusion Criteria:

* Collection of the written consent by the patients or the parents
* Membership in a health insurance scheme
* Group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst

Exclusion Criteria:

* Refusal of participation of the patient or one of the two parents
* Deprived of freedom
* Pregnancy and current feeding
* Prenatal, neonatal or infantile history of ovarian pathology (Group 2)
* Genital congenital deformation or malformation syndrome gives a complex (group 2)
* Endocrine pathology except the juvenile disorders (group 2)

Primary outcomes:
measure: Age of puberty
timeFrame: 1 day
Secondary outcomes:
measure: Follicular reserve
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier cedex 5
country: France
facility: Hôpital Lapeyronie
Study officials:
affiliation: Montpellier University Hospital
name: Nicolas KALFA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06282367: Bowel Preparation for Colonoscopy With Oral Lactulose
Official title: Novel Regimen for Colonoscopy Bowel Preparation With Oral Lactulose: A Prospective Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Colonoscopy Preparation
Keywords: bowel preparation
oral lactulose
colonoscopy
Lead sponsor: Hospital Jose Agurto Tello
Sponsor class: OTHER_GOV
First posted: 2024-02-28
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data were extracted from a prospectively generated database, including consecutive outpatients from July 2021 to April 2023 who underwent diagnostic colonoscopy

Brief summary: Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.

Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects.


Eligibility criteria: Inclusion Criteria:

* Patients age ≥ 18 years
* Colorectal cancer screening
* Lower gastrointestinal bleeding
* Iron deficiency anemia
* Chronic diarrhea

Exclusion Criteria:

* Patients with previous colorectal surgery
* Pregnant
* Emergency colonoscopies
* Use of any other scheme or substance for bowel preparation different from those studied
* Incomplete information
* Clinical conditions considered unsuitable for sedation or colonoscopy

Primary outcomes:
measure: Degree of bowel cleansing using the Boston score
timeFrame: 21 month
Secondary outcomes:
measure: adenomas detection rate
timeFrame: 21 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Jose Agurto Tello Hospital
Study officials:
References:
Clinical trial NCT06886867: Comparing Exergaming and Usual Care Physical Therapy in Nursing Home Residents
Official title: Physical Function in Older Adults: Exergaming vs. Usual Care in Physical Therapy - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Adults Institutionalized in Residential Homes
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to compare the effects of exergaming and usual care physical therapy on physical function in older adults residing in nursing homes.

This trial seeks to answer the following key questions:

* Does physical function differ between interventions after treatment?
* How do these interventions impact enjoyment of therapy?
* Are there differences in adherence or perceived exertion between the interventions?

Detailed description: A single-blind, randomized controlled trial will be conducted to compare exergaming and usual care interventions. Participants will be recruited from nursing homes in the province of Toledo, and the study will follow the CONSORT guidelines for clinical, crossover, and parallel trials.

Two experimental groups will be tested, with interventions performed three days per week for six weeks, each session lasting approximately 30 minutes. The exergaming group will play seven video games from the Party Fowl app, while the usual care group will continue their standard exercise routine.

Outcome measures will be assessed at baseline, post-intervention (6 weeks), and at a 3-month follow-up to evaluate the middle-term effects of both interventions.

Eligibility criteria: Inclusion Criteria:

* subjects over 60 years of age
* score equal to or greater than 20 on the Mini Mental cognitive test
* Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.

Exclusion Criteria:

* severe visual impairment
* medical contraindication for physical activity
* pathology or problem that could prevent the test from being carried out.

Primary outcomes:
measure: Physical function
timeFrame: Baseline, post-intervention (6 weeks) and 3 months follow-up.
Secondary outcomes:
measure: Hand grip strength
timeFrame: Baseline, post-intervention (6 weeks) and 3 months follow-up.
measure: Exercise enjoyment
timeFrame: Post-intervention (6 weeks)
measure: Rate of Perceived Exertion
timeFrame: RPE will be measured inmediatley after the intervention
measure: Adherence
timeFrame: Through study completion (6 weeks), with a final adherence percentage calculated at the end of the intervention.
Other outcomes:
Locations:
city: Fuensalida
country: Spain
facility: Nueva Esperanza Nursing Home
state: Toledo
city: Toledo
country: Spain
facility: Universidad de Castilla-La Mancha
Study officials:
References:
Clinical trial NCT03289767: Simple Preparation of Endotracheal Tube
Official title: Simple Preparation of Endotracheal Tube for Optimal Angulation During Intubation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Tube
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To observe the effect of additional E-tube angulation on intubation time and success rate.

Detailed description: The hypothesis of this study is that shaping endotracheal tube by end-to-end connection before induction will provide more optimal angulation for endotracheal intubation.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation

Exclusion Criteria:

* Patients with congenital or acquired upper airway lesions
* Patients with high risk of aspiration

Primary outcomes:
measure: Successful intubation on first attempt
timeFrame: On endotracheal intubation up to 1 min
Secondary outcomes:
measure: Time to intubate (TIT)
timeFrame: On endotracheal intubation up to 1 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hwa Seo, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01172067: QuickOpt Chronic Study
Official title: Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: CRT
heart failure
optimization
Timing cycle optimization methods
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-07-29
Enrollment: 400
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 of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。

Detailed description: Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99.

But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.

Eligibility criteria: Inclusion Criteria:

* • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system

  * Patient is able to provide written informed consent for study participation

Exclusion Criteria:

* • Patient has limited intrinsic atrial activity (≤ 40 bpm)

  * Patient has persistent or permanent AF
  * Patient has a 2o or 3o heart block
  * Patient's life expectancy is \<12 months
  * Patient is \<18 years old
  * Patient is pregnant
  * Patient is on IV inotropic agents
  * Patients who are ongoing other devices or agents study
  * Patients with heart transplanted or waiting for heart transplant
  * Patients with Hypertrophic and obstructive cardiomyopathy
  * Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement

Primary outcomes:
measure: Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
timeFrame: Baseline and12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01368367: Exercise Training Post Burn Injury
Official title: Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Keywords: Burns
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Royal Brisbane and Women's Hospital
First posted: 2011-06-07
Enrollment: 36
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 of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.

Detailed description: Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.

This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.

Eligibility criteria: Inclusion Criteria:

* Burns greater than 20% total body surface area
* 18 years of age and over
* English speaking
* Post final grafting procedure

Exclusion Criteria:

* Accompanying anoxic brain injury
* Cardiac disease or injury (American College of Sports medicine ACSM criteria)
* Quadriplegia
* Severe behaviour or cognitive disorders
* Compassionate care only

Primary outcomes:
measure: Burns Specific Health Scale - Abbreviated (BSHS-A)
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcomes:
measure: The modified shuttle walk test (MSWT)
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
measure: VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test)
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
measure: Resting heart rate (beats/minute)
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
measure: Muscle strength
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
measure: Grip strength
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
measure: QuickDash
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
measure: The Lower Extremity Functional Scale (LEFS)
timeFrame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane & Womens Hospital
state: Queensland
Study officials:
References:
Clinical trial NCT02167867: Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs
Official title: Evaluation of Efficacy, Usability and Labeling Comprehension for Over-the-Counter Use of the Erchonia Corporation ZERONA® Z6 for Body Contouring of the Waist, Hips and Thighs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumference Reduction
Keywords: body contouring
circumference reduction
body shaping
low level laser
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.

Detailed description: The Erchonia ZERONA® Z6 is a low level laser light therapy device that has been approved by the United States Food and Drug Administration (FDA) for use by licensed medical professionals to help to reduce the circumference of the hips, waist and thighs.

This study is to see if the Erchonia ZERONA® Z6 can be used by lay (non-medical professional) people to treat others to help to reduce the circumference of the hips, waist and thighs.

Eligibility criteria: Lay End Users

Inclusion Criteria:

* 18 years of age or older
* Able to read and write English.
* Employees of the study test sites

Treatment Subjects

Inclusion Criteria

* 18 years of age or older
* Body Mass Index (BMI) \<= 30 kg/m2

Exclusion Criteria

* Pregnancy
* Open wounds (sores, cuts, ulcers, etc.) on or around the waist, hips and/or thighs
* Currently have or are being treated for any cancerous growths on or around the waist, hips and/or thighs

Primary outcomes:
measure: Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments
timeFrame: Baseline
measure: Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.
timeFrame: two weeks
measure: Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6
timeFrame: Baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Lifetime Fitness
state: Colorado
Study officials:
name: Joseph Zapolsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277367: Vitality Health Incentives for Physical Activity
Official title: A Prospective, Randomized Clinical Trial Comparing the Effectiveness of Different Types of Incentives in Increasing Physical Activity Behavior on the Vitality Health Promotion Programme
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
Sedentary
Physical activity
exercise
incentives
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 0
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: The aim of the study is to prospectively compare the effectiveness of diverse incentives on physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality health promotion programme based in South Africa.

Detailed description: Newly enrolled adult members of the Discovery Health medical plan who have, themselves, prospectively registered for the Vitality health promotion programme will be eligible for the study, and will be invited to participate by Discovery Vitality. A final sample of 9000 adult members, who are recruited and have agreed to participate, will be randomly allocated by Discovery Vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed for six months.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* enrolled in Vitality

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
measure: Engagement in physical activity
timeFrame: 6 months
Secondary outcomes:
measure: Fitness points earned
timeFrame: 6 months
measure: Gym visits
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
city: Cape Town
country: South Africa
facility: University of Cape Town
city: Johannesburg
country: South Africa
facility: Discovery Vitality
Study officials:
affiliation: Discovery Holdings, LTD
name: Deepak Patel, MD
role: STUDY_CHAIR
References: