louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03436888: Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
Official title: Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Girdle Pain
Pregnancy Related
Postpartum Period
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 134
Sex: FEMALE
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: Adult pregnant or in postpartum period females suffering of pelvic girdle pain. The symptoms must occur during pregnancy or within 3 weeks after childbirth.

Brief summary: The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.


Eligibility criteria: Inclusion Criteria:

* Women from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system.

Exclusion Criteria:

* Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.

Primary outcomes:
measure: Disability
timeFrame: up to ten days
Secondary outcomes:
measure: Disability: Oswestry disability index
timeFrame: 1 day (First appointment)
measure: fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire
timeFrame: 1 day (First appointment)
measure: Pain Catastrophizing: Pain catastrophizing scale
timeFrame: 1 day (First appointment)
measure: health-related quality of life: SF 8 scale
timeFrame: 1 day (First appointment)
measure: Pain: Visual Analogue Pain Rating Scale
timeFrame: 1 day (First appointment)
Other outcomes:
Locations:
city: Caen
country: France
facility: Pôle de Santé de la Grâce de Dieu
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT03566888: Validation of a Noninvasive Automated Blood Pressure Device
Official title: Validation of a Noninvasive Automated Blood Pressure Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 12-92 years, generally healthy, and have not been diagnosed with heart disease.

Brief summary: The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.

Detailed description: A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.

Eligibility criteria: Inclusion Criteria:

* between the ages of 12 to 92 years of age.
* generally healthy but can be on medication for blood pressure regulation.

Exclusion Criteria:

* heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs.
* using a pacemaker to maintain a suitable heart rate.
* missing their natural left arm.
* exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time (\~40min) or prevent a BP reading taken from the left arm.
* Special populations, for example pregnant women and patients with known arrhythmias.

Primary outcomes:
measure: Systolic and Diastolic blood pressure (criteria 1 and 2)
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Todd Schroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05745688: Gender Bias and Overtreatment in Primary Care
Official title: Epidemiological Study on Gender Bias and Overtreatment in Primary Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Any Condition
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
First posted: 2023-02-27
Enrollment: 1048000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults attending primary care consultation from 1 January 2022 to 31 December 2022

Brief summary: The purpose of this study is to analyze if there are differences between men and women in the frequency of ignoring "Do not do" recommendations in primary care setting.

Detailed description: First, using the Delphi technique, a consensus will be reached on those "Do Not Do" recommendations that should be included in the retrospective analysis study. The selection criteria for these recommendations will be if they are about pharmacological treatments, considered to persist in clinical practice in primary care, their relationship with factors associated with sex and gender, and if ignoring the "Do not do" recommendation could cause a serious adverse event.

Second, a retrospective cohort study will be carried out including patients who attended primary care consultation in Alicante from 1st January 2022 to 31st December 2022. Data source will be the electronic record management system of the autonomous community of Valencia (named ABUCASIS), and they will be provided by the Ambulatory Assistance Information System (SIA-GAIA). Investigators will analyze the frequency of ignoring the "Do not do" recommendations previously selected by consensus by sex and age range.

Eligibility criteria: Inclusion Criteria:

* Attending primary care consultation from 1 January 2022 to 31 December 2022.
* Adults

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of female patients who were recommended "do not do"
timeFrame: From 1st January 2022 to 31 December 2022
measure: Number of male patients who were recommended "do not do"
timeFrame: From 1st January 2022 to 31 December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: Hospital San Juan de Alicante
state: Alicante
Study officials:
References:
Clinical trial NCT05187988: Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach
Official title: Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brachial Plexus Block
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study investigators will compare two different approaches of brachial plexus block ;supraclavicular approach and retroclavicular approach regarding success rate, duration of block, complications


Eligibility criteria: Inclusion Criteria:

* 100 patients doing distal arm surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.

Exclusion Criteria:

* Patient refusal .
* local infection or deformity at the block site.
* Patient with significant neurological , psychiatric or neuromuscular disease.
* Pregnancy or lactating women .
* Coagulopathy .
* Morbid obesity .
* History of allergy to local anaesthetics

Primary outcomes:
measure: Block success rate
timeFrame: one year
measure: Complications
timeFrame: one year
measure: Duration of sensory and motor blockade
timeFrame: one year
Secondary outcomes:
measure: Duration of procedure
timeFrame: one year
measure: Number of needle passes
timeFrame: one year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.
citation: Yazer MS, Finlayson RJ, Tran DQ. A randomized comparison between infraclavicular block and targeted intracluster injection supraclavicular block. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):11-5. doi: 10.1097/AAP.0000000000000193.
citation: Charbonneau J, Frechette Y, Sansoucy Y, Echave P. The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):605-9. doi: 10.1097/AAP.0000000000000284.
citation: Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
Clinical trial NCT01443988: Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost
Official title: A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent) or Travoprost Ophthalmic Solution 0.004%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Keywords: Open angle glaucoma
POAG
Ocular hypertension
Pseudoexfoliative glaucoma
Naïve to treatment
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 101
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: Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Detailed description: Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Eligibility criteria: Inclusion Criteria:

* Phakic study eye
* IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening)

Exclusion Criteria:

* Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
* Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Primary outcomes:
measure: Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan Ophthalmological Center
Study officials:
affiliation: S.V. Malayan Ophthalmological Center, Yerevan, Armenia
name: Lilit A Voskanyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. doi: 10.1007/s40123-016-0065-3. Epub 2016 Sep 12.
Clinical trial NCT01616888: Paclitaxel Eluting Balloon for SFA In-stent Restenosis
Official title: Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: In-stent Arterial Restenosis
Keywords: drug eluting balloon with paclitaxel
in stent restenosis
femoropopliteal arteries
angioplasty
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 30
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: The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.

Detailed description: Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5
* in-stent restenosis or occlusion in SFA or PPA 20mm - 200mm

Exclusion Criteria:

* participation in another investigational drug or device trial
* life expectancy less than 12 months
* acute ischemia and/or acute thrombosis of the SFA/PPA

Primary outcomes:
measure: Target lesion patency at 6-month follow-up.
timeFrame: 6-month post index procedure
Secondary outcomes:
measure: Clinical success up to 12 months post index procedure
timeFrame: 12 months post index procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kong Teng Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06191588: Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis
Official title: Feasibility and Effectiveness of Home-base Early Intensive Therapy in Unilateral Cerebral Palsy (Ucp-HEIT) Under-2-years-old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Hemiplegia
Constraint Induced Movement Therapy
Family
Bimanual Intensive Therapy
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by families.


Eligibility criteria: Inclusion Criteria:

* Infantile hemiplegia
* Age from 9 months to 18 months.
* No use of the affected upper limb

Exclusion Criteria:

* Associated pathologies
* Epilepsy no controlled with drugs
* No collaborated families

Primary outcomes:
measure: mini Assisting Hand Assesment
timeFrame: 10 weeks
Secondary outcomes:
measure: Satisfaction questionnaire for families
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Elena Piñero Pinto
city: Seville
country: Spain
facility: Elena Piñero Pinto
Study officials:
References:
Clinical trial NCT03910088: Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean
Official title: Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Dural Puncture Headache
Keywords: spinal
cesarean
pregabalin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.

Detailed description: The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent elective cesarean section under spinal anesthesia.
* Patients aged 18 to 40 years old.
* Patients classified as ASA I or II.

Exclusion Criteria:

* Patients with known sensitivity to any of the used drugs.
* Patients classified as ASA III or more.
* Preeclampsia.
* Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.

Primary outcomes:
measure: Assessment of pain using Visual Analogue Scale
timeFrame: the first 48 hours following treatment
Secondary outcomes:
measure: Assessment of the amount of rescue drug
timeFrame: The first 48 hours following treatment
measure: incidence of side effects of the studied drug
timeFrame: the first 48 hours following treatment
measure: incidence of side effect of the studied drug
timeFrame: the first 48 hours following treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Zamalek
Study officials:
References:
Clinical trial NCT04956588: Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
Official title: A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial to Evaluate the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spine Disease
Spinal Fractures
Keywords: smart orthopedics
minimally invasive surgical systems
spinal surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Shenzhen Second People's Hospital
First posted: 2021-07-09
Enrollment: 60
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: To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.


Eligibility criteria: Inclusion Criteria:

- Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.

Exclusion Criteria:

- Subject meeting the exclusion criteria; People with metal allergy; Women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; Subjects with coagulation dysfunction; Subjects who have failed spinal surgery and need a second operation; Subjects with spinal tumors, deformities and slippery vertebrae; Candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; Any other circumstances in which the Investigator deems it inappropriate to participate in this study.

Primary outcomes:
measure: Incorrect placement of guide pin
timeFrame: During operation
measure: Number of X-ray exposures
timeFrame: During operation
measure: X-ray exposure time
timeFrame: During operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT00978588: Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valvular Heart Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass


Eligibility criteria: Inclusion Criteria:

* Mitral valvular heart disease

Exclusion Criteria:

* Status of Infection
* Re-operation
* Liver failure
* Renal disease
* Administration of steroid

Primary outcomes:
measure: the pure effect of priming solutions
timeFrame: after CPB
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Young Lan Kwak, M.D.,PhD,
role: PRINCIPAL_INVESTIGATOR
References: