louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05339516: The Association Between Urinary Incontinence, Physical Performance, Physical Activity Levels in Women With Low Back Pain
Official title: The Association Between Urinary Incontinence, Physical Performance and Physical Activity Level in Women With Low Back Pain a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Physical Inactivity
Urinary Incontinence
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 146
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30-65 ages women who live in city of Isparta in Turkey.

Brief summary: The study is searching for the correlation between low back pain(LBP), physical performance, urinary incontinence and physical activity levels in women. Lower physical performance, more frequent urinary incontinence and less physical activity are expected in women who have LBP.


Eligibility criteria: Inclusion Criteria For Healthy Group:

* 30-65 years women
* Agreeing to involve in the study

Inclusion Criteria For Women With Low Back Pain Group:

* 30-65 years women
* Having low back pain for at least 3 months
* Scoring pain at least 1 in Visual Analog Scale(VAS)
* Agreeing to involve in the study

Exclusion Criteria:

* Any kind of surgery history in low back area
* Surgery history in lower limbs
* Acute low back pain
* Having a neurological disease
* Having sensory deficists
* The ones with rheumatological diseases which can cause low back pain
* Being pregnant
* Having a disc hernia pressuring to sacral nerves

Primary outcomes:
measure: Visual Analog Scale(VAS)
timeFrame: Baseline
measure: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
timeFrame: Baseline
measure: International Physical Activity Questionnaire(IPAQ)
timeFrame: Baseline
measure: Muscle Strength Testing
timeFrame: Baseline
measure: Endurance Testing
timeFrame: Baseline
measure: Agility Testing
timeFrame: Baseline
measure: Flexibility Testing
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT01284816: Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function
Official title: Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severely Obese Patients
Keywords: severely obese patients
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER

Brief summary: Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.

The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.

Detailed description: The best of our knowledge, no study has really addressed whether this EAT was modulated by diet or therapeutics like bariatric surgery. The researchers were particularly interested in studying the impact of bariatric surgery and of weight loss on the amount of EAT and whether reduction in EAT could have a positive impact on myocardial function.

Eligibility criteria: Inclusion Criteria:

* men or women who have more than 18 years
* patients have been informed and have consented
* severely obese patients with surgery indication

Exclusion Criteria:

* contraindications at surgery, at MNR imagery
* History of infarct, of congenital cardiomyopathy
* Treatment modifying the distribution of the fat
* Pregnant or breast-feeding women
* patients less than 18 years
* Patient without consentment

Primary outcomes:
measure: The change in EAT amount 6 months after bariatric surgery.
timeFrame: 36 months
Secondary outcomes:
measure: Evaluation of 3 parameters
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM
Study officials:
affiliation: AP-HM
name: Anne Dutour, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaborit B, Jacquier A, Kober F, Abdesselam I, Cuisset T, Boullu-Ciocca S, Emungania O, Alessi MC, Clement K, Bernard M, Dutour A. Effects of bariatric surgery on cardiac ectopic fat: lesser decrease in epicardial fat compared to visceral fat loss and no change in myocardial triglyceride content. J Am Coll Cardiol. 2012 Oct 9;60(15):1381-9. doi: 10.1016/j.jacc.2012.06.016. Epub 2012 Aug 29.
Clinical trial NCT04003116: Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)
Official title: Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Lead sponsor: Ministry of Health, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2019-07-01
Enrollment: 70
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 primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.

The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
* Disfunction of right ventricle (RV to left ventricle \[LV\] diameter ratio \>1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
* Signed and dated informed consent of the subject.

Exclusion Criteria:

* \<18 years old.
* Allergy to iodinated contrast.
* Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
* Use of chronic oxygen therapy.
* Hypercapnia (pCO2 \>50 mmHg at the time of diagnosis).
* Technically inadequate basal echocardiography.
* Contraindication to anticoagulant therapy.
* Symptoms duration \>10 days.
* Haemodynamic instability.
* Participation in other clinical trial for PE treatment during the present clinical trial.
* Inability to use mask or nasal prongs.
* Life expectancy less than 90 days.

Primary outcomes:
measure: Normal right ventricle function at 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Modification RV -LV 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital Universitario Araba
state: Alava
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: IRYCIS, Alcala de Henares University
name: David Jiménez
role: STUDY_CHAIR
References:
Clinical trial NCT01668316: Get Active and Eat Right: Moms at Work
Official title: Get Active and Eat Right: Moms at Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obese
Postpartum
Weight loss
Inflammation
Obesity
Cardiovascular
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of a worksite diet and exercise program on weight loss in postpartum women.

Detailed description: This project is a research study investigating the effects of a worksite diet and exercise intervention on weight loss in overweight postpartum women. Weight loss programs have been shown to be effective in reducing postpartum weight retention. However, high attrition rates in these studies suggest that the added responsibility of a new infant at home and returning to work may limit a woman's ability to follow a diet plan and exercise regularly. We hope that by offering a weight loss program at the workplace, we can increase participant retention and maximize weight loss in this population. Our primary aim is to promote weight loss while preserving lean body mass during the 12 week intervention. Secondary aims include increasing cardiovascular fitness from baseline and improving cardiovascular biomarkers, including total, LDL, and HDL cholesterol, triglycerides, glucose, insulin, and markers of inflammation and metabolism.

Eligibility criteria: Inclusion Criteria:

* 18 years and older, 10 to 14 weeks postpartum, University faculty, staff, and students, BMI 25-35 or at least 4.5 kilograms heavier than prepregnancy weight, English speaking

Exclusion Criteria:

* Smoking, chronic disease, BMI \>35

Primary outcomes:
measure: Weight loss and change in body composition
timeFrame: 12 weeks
Secondary outcomes:
measure: Cholesterol
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: University of North Carolina at Greensboro
state: North Carolina
Study officials:
affiliation: University of North Carolina, Greensboro
name: Cheryl Lovelady, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06789016: Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
Official title: Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Scoliosis Idiopathic
Scoliosis
Scoliosis; Adolescence
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Detailed description: This study proposes to explore the effect of perineurial Dexmedetomidine on the duration of erector spinal plane block for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Eligibility criteria: Inclusion Criteria:

* children scheduled for idiopathic scoliosis surgery
* age \>10 and \<18 years

Exclusion Criteria:

* age \< 10 years
* age \< 18 years
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use

Primary outcomes:
measure: First need of opioid analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 48 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 12 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 24 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 48 hours after surgery
measure: adverce effects
timeFrame: durring surgery
measure: adverce effects
timeFrame: 48 hours after surgery
measure: MEP
timeFrame: durring surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
Study officials:
References:
Clinical trial NCT05286216: The Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients
Official title: The Effect of Education on Oral Antiviral Use on Medication Compliance and Quality of Life in Patients With Hepatitis-B Diagnosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B, Chronic
Adherence, Medication
Quality of Life
Keywords: chronic hepatitis B
adherence, medication
quality of life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effect of the education given to patients with CHB who use oral antiviral drugs on oral antiviral drug use on drug compliance and quality of life.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with CHB for at least 6 months,

  * To be over 18 years old,
  * Using oral antiviral treatment for at least three months,
  * To be a literate person,
  * No malignancy other than hepatocellular carcinoma,
  * Not having vision and hearing problems,
  * Not having cognitive or psychiatric problems,
  * Patients/patient relatives who can use smartphones (In order to invite the patients to the 3rd and 6th month controls and to inform and remind the experimental group about the training time, they / their relatives should have and can use a mobile phone)
  * Volunteer to participate in the study.

Exclusion Criteria:

* •Continuing to use alcohol after the first evaluation,

  * Not willing to participate in the study,
  * Patients with a psychiatric diagnosis,
  * Patients who do not meet the sample inclusion criteria.

Primary outcomes:
measure: Medication Adherence Report Scale-5
timeFrame: 24 weeks
measure: MedTake Test
timeFrame: 24 weeks
measure: Liver Disease Symptom Index 2.0
timeFrame: 24 weeks
measure: Composite 12 İtem Short Form Health Survey
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06864416: Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine
Official title: Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine in Femero Sciatic Block for Below Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 20
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: Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit

Detailed description: Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit, Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics like bupivacaine can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Based on "Combination Wisdom", the use of adjuvants to local anesthetics has been promoted a lot .A wide variety of drugs have been used for both neuraxial and peripheral nerve blocks, and the most commonly used drug as adjuvant is the fentanyl .

The addition of dexmedetomidine during US-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years.
* American Society of Anesthesiologists (ASA) physical status I-II,
* Scheduled for elective surgery below the knee.

Exclusion Criteria:

* Allergies to used medications.
* Coagulopathy.
* Septic patients.
* Neurological disease.
* Respiratory or cardiac disease.
* Diabetes mellitus.
* Patients' refusal to participate.

Primary outcomes:
measure: Visual analogue score assessment
timeFrame: 6 hours from performing the block
Secondary outcomes:
measure: The time of first analgesics required
timeFrame: Immediately after the end of the surgery and for 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, abbasia
Study officials:
References:
Clinical trial NCT00200616: Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
Official title: Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Urinary tract infection
Vesico-renal reflux
Child
Antimicrobial prophylaxis
Recurrence of urinary tract infection
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 232
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).

Detailed description: A voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. Duration of follow up was 18 months.

Eligibility criteria: Inclusion Criteria:

* Children less than 3 years old
* First proved urinary tract infectionIsolated vesico-ureteral reflux
* Parents have been fully informed and have given written informed consent to participate in the study

Exclusion Criteria:

Primary outcomes:
measure: End point : recurrence of urinary tract infection during the study period (0 è 18 months)
Secondary outcomes:
measure: 1) Type of urinary tract infection (pyelonephritis or cystitis)
measure: 2) Evaluation of the quality of life with a validated questionnaire done at 9 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Claude GUYOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03145116: Clinical Safety and Efficacy of CT ASPHINA 509 Lenses
Official title: Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation


Eligibility criteria: Inclusion Criteria:

Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;

* Patients of any gender
* Assured follow-up examinations
* Biometry measurement preferably compatible with the IOLMaster evaluation;
* IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
* Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria:

* • BCVA not available preoperatively or better than 0.3 logMAR pre-op

  * Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
  * Patients whose freedom is impaired by administrative or legal order
  * Concurrent participation in another drug or device investigation

Primary outcomes:
measure: Visual acuity
timeFrame: 12 to 18 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ahaus
country: Germany
facility: Augenklinink
Study officials:
References: