louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04412928: Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure
Official title: Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 591
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women with stress urinary incontinence who underwent mid-urethral sling procedure.

Brief summary: We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors.

Detailed description: At present, around 30% of women with stress urinary incontinence have overactive bladder syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors. In addition, we will explore the cure rate and predictors of cure of overactive bladder syndrome after the mid-urethral sling procedure for women with stress urinary incontinence. The above results will be used as a reference for preoperative and postoperative consultation.

Eligibility criteria: Inclusion Criteria:

* All women with stress urinary incontinence who underwent mid-urethral sling procedure from January 01, 2008 to July 31, 2019 will be reviewed.

Exclusion Criteria:

* Patients undergoing other gynecological operations at the same time, except for cystoscopy.

Primary outcomes:
measure: Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure
timeFrame: 10 year
Secondary outcomes:
measure: Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT03460028: Yoga for Persistent Pain Related to Oncology Surgery
Official title: Evaluation of the Transitional Pain Service Surgical Oncology Yoga Program for Individuals With Persistent Pain; a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Postoperative Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will evaluate a yoga intervention for individuals who experience persistent pain following oncology surgery. The integrated yoga program will involve postures, breathing exercises, and concentration practices. Data will be collected at several time points (pre-, mid-, and post-intervention) for both the intervention and wait-list control conditions. The data will be analysed using linear mixed effects growth models. Results will be written up in manuscript format, published in a peer review journal, and disseminated at scientific research conferences.


Eligibility criteria: Inclusion Criteria:

1. Is a patient at specific pain clinics
2. Has undergone oncology surgery prior to commencing the yoga intervention
3. Is 18 years of age or older
4. Is able to speak and read English
5. Is able to commit to one weekly, one hour yoga classes for eight weeks
6. Is able to provide a note from their physician or kinesiologist indicating that it is safe for them to participate in a gentle physical activity intervention, such as yoga

Exclusion Criteria:

1. Has pre-existing medical contraindications that preclude participation
2. Has cognitive limitations or language comprehension issues that would impact participation
3. Have had a regular yoga practice in the last six months
4. Documented personality disorder
5. Pregnant women
6. Current enrollment in another research trial evaluating a mind-body intervention

Primary outcomes:
measure: Change in scores on the Pain Catastrophizing Scale
timeFrame: at 0, 4 and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT02474628: Consistencies in Responses to Sodium Bicarbonate?
Official title: Consistencies in Responses to Sodium Bicarbonate Supplementation: a Randomised, Repeated Measures, Counterbalanced and Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Nutritional Physiological Phenomena
Keywords: Physiological Phenomena
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. The investigators aim to determine the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active males will complete six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise outcome.


Eligibility criteria: Inclusion Criteria:

* recreationally active males

Exclusion Criteria:

* use of dietary supplements in the past 6 months
* the presence of any musculoskeletal disorder
* the use of anabolic steroids

Primary outcomes:
measure: blood pH
timeFrame: 5 min after a physical exercise test
Secondary outcomes:
measure: blood bicarbonate
timeFrame: 5 min after a physical exercise test
measure: blood lactate
timeFrame: 5 min after a physical exercise test
measure: anaerobic exercise capacity
timeFrame: 4 hours after supplementation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
References:
citation: Froio de Araujo Dias G, da Eira Silva V, de Salles Painelli V, Sale C, Giannini Artioli G, Gualano B, Saunders B. (In)Consistencies in Responses to Sodium Bicarbonate Supplementation: A Randomised, Repeated Measures, Counterbalanced and Double-Blind Study. PLoS One. 2015 Nov 17;10(11):e0143086. doi: 10.1371/journal.pone.0143086. eCollection 2015.
Clinical trial NCT02720328: Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants
Official title: Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Embolism and Thrombosis
Hemorrhage
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators also aim at identifying the underlying causes of these preventable ADRs. The endpoint measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs). For this purpose, a protocol for a prospective observational study was developed. The study was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques Universitaires Saint-Luc. Patients admitted to the emergency department of these two teaching hospitals with a thrombotic or a bleeding event while under DOAC or VKA are included. After a comprehensive medication history, the appropriateness of prescribing is evaluated, using an adapted version of the Medication Appropriateness Index. Causality, severity and preventability of adverse events are assessed by two pharmacists and two hematologists using predefined scales. Second, for cases of serious and preventable ADRs, semi-structured interviews are performed with general practitioners to understand the underlying causes of medication errors. Based on the results, risk-minimization strategies that specifically target the problems encountered in clinical practice will be proposed.


Eligibility criteria: Inclusion Criteria:

* Admitted to the emergency department
* Presenting a thrombotic or a bleeding event
* Prescribed NOAC (rivaroxaban, dabigatran etexilate or apixaban) or VKA

Primary outcomes:
measure: Preventability of adverse drug reactions according to Hallas criteria
timeFrame: Baseline
Secondary outcomes:
measure: Appropriateness of prescribing according to the Medication Appropriateness Index
timeFrame: Baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Yvoir
country: Belgium
facility: CHU UCL Namur site Godinne
Study officials:
References:
Clinical trial NCT06268028: Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery
Official title: The Effect on the Level of Readiness for Discharge of Discharge Training Given to Primiparous Mothers Having a Cesarean Delivery : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training
Keywords: Training of discharge
Caesarean section
Primiparous
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.

The research is a pre-test-post-test, randomized controlled experimental study.

Detailed description: The research is a pre-test-post-test, randomized controlled experimental study. To prevent selection bias, participants were included in the training and control groups by applying the randomization method. The sample consisted of a total of 70 women (experimental group: 35 women and control group: 35 women). The study was carried out with women who lying to Obstetrics Clinic of Aydın Gynecology and Children's Diseases Hospital and met the study criteria.

Eligibility criteria: Inclusion Criteria:

* Able to speak and understand Turkish,
* At least primary school graduate,
* 18 years and over,
* Those who gave birth by cesarean section,
* Primiparous mothers will be included in the research.

Exclusion Criteria:

* Those who have a physical disability (vision, hearing, etc.) that prevents them from taking care of themselves,
* In a risky postpartum period,
* Having a history of chronic disease,
* Those who were hospitalized during pregnancy,
* Those who do not have their baby with them after birth,
* Foreign nationals,
* Mothers with psychiatric diagnoses will not be included in the study.

Primary outcomes:
measure: A pre-test applied to 70 women who constitute the sample of the research.
timeFrame: 16 weeks
Secondary outcomes:
measure: Apost-test applied to 70 women who constitute the sample of the research.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Maternity and Child Health Hospital
Study officials:
affiliation: Res.assist
name: BELMA TOPTAŞ ACAR, Res.assist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490528: Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Inflammatory Bowel Disease
Keywords: Pediatric IBD
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 200
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent

Brief summary: There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children.

The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab.

The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab.

Safety outcomes will focus on frequency of malignancies, infections and immunogenecity


Eligibility criteria: Inclusion Criteria:

* All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent

Exclusion Criteria:

* not exposed to infliximab

Primary outcomes:
measure: Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab
timeFrame: 10 years
Secondary outcomes:
measure: Frequency of concomitant immunomodulator use in children on infliximab
timeFrame: 10 years
measure: Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Cedar Sinai Medical Center
name: Marla Dubinsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05776628: Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
Official title: Evaluation of the Performance and Safety of Plenum® Tissue Ortho for the Prevention of Epidural Fibrosis and Post-laminectomy Syndrome After Microdiscectomy, for the Treatment of Disc Herniation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Herniated Disk Lumbar
Lead sponsor: M3 Health
Sponsor class: INDUSTRY
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
First posted: 2023-03-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare if adding a polydioxanone membrane prevents epidural fibrosis and, consequently, the rate of occurrence of the post-laminectomy syndrome in participants undergoing microdiscectomy for treatment of disc herniation.

Detailed description: Participants will be submitted to microdiscectomy with the addition of a polydioxanone membrane over the dura mater in the test group and without in the control group.

The groups will be compared regarding improving patients' quality of life, evaluation of epidural fibrosis, and device safety.

Eligibility criteria: Inclusion Criteria:

* Pain radiating to one of the legs confirmed with an MRI scan;
* Patients who have already undergone conservative treatment (treatment with medication and physiotherapy) for at least 6 weeks, but have not shown improvement;
* Non-pregnant women or women of childbearing age who use contraceptive methods;
* Having signed the free and informed consent form (TCLE).

Exclusion Criteria:

* Patients with concomitant pathologies (eg infection or tumor and segmental instability or vertebral fractures);
* Cauda equina syndrome;
* Strength deficit characterized by strength equal to or less than III/V;
* Previous surgery of the lumbar spine;
* Patientes who have wound healing disorders;
* Patients with contraindications for evaluating MRI with the use of contrast;
* More than 1 herniated disk.

Primary outcomes:
measure: Patient's quality of life
timeFrame: Change from the baseline, to immediate potostoperative period (14 days) and to late postoperative period (6 months).
Secondary outcomes:
measure: Epidural fibrosis
timeFrame: 6 months postoperatively.
measure: Patient's quality of life
timeFrame: Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).
measure: Low back and leg pain
timeFrame: Before the procedure, in the immediate postoperative period (14 days) and in the late postoperative period (6 months).
measure: Intervention safety
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Jundiaí
country: Brazil
facility: M3 Health
state: São Paulo
Study officials:
affiliation: M3 Health
name: Sybele Saska Specian, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00484328: Ribavirin, Its Dosing Regime
Official title: Ribavirin, Its Dosing Regime
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: hepatitis C
Ribavirin
Dosage
Pharmacokinetics
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2007-06-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

Detailed description: The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.

The pharmacokinetics of ribavirin at different dosage regimes is investigated.

Eligibility criteria: Inclusion Criteria:

* anti-HCV positivity \> 6 months
* Positive HCV-RNA genotype 1 or 4
* Liver biopsy within one year before the start of therapy
* Intention to be treated and participate treatment
* body weight at or above 75 kg

Exclusion Criteria:

* HIV positive

Primary outcomes:
measure: The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
timeFrame: within 24 weeks after enrollment
Secondary outcomes:
measure: The tolerability of the treatment at different dosage regimes of ribavirin
timeFrame: 24 weeks of treatment
measure: The antioxidant capacity in plasma and erythrocytes at different dosing regimes
timeFrame: 24 weeks of treatment
measure: The effect of ribavirin on the hemolysis
timeFrame: 24 weeks of treatment
measure: The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes
timeFrame: 24 weeks of treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University of Maastricht
Study officials:
affiliation: Maastricht University
name: Aalt Bast, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04011228: Epigenetics Based Diagnosis of Diabetes in Saliva and Blood Samples
Official title: Sex-specific Relationship of Epigenetics Based Modifications in the Saliva and Blood With the Occurence of Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediabetic State
Diabetes Mellitus, Type 2
Ectopic Lipids
Epigenetics Based Modifications
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the present study prediabetic patients, type 2 diabetic patients, women with gestational diabetes and healthy control subjects will be included.

Brief summary: The aim of the present study is to investigate epigenetics based modifications and biomarkers in the saliva and blood in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patients
* prediabetic patients
* women with gestational diabetes
* healthy control subjects without diabetes
* healthy pregnant women

Exclusion Criteria:

* cancer disease
* infectious diseases such as hepatitis or HIV
* malignoms
* patients with claustrophoby

Primary outcomes:
measure: Specifying the microRNAs in saliva in diabetic patients
timeFrame: 1 hour
Secondary outcomes:
measure: Correlation of the percentage of liver fat with miRNA´s in diabetic patients.
timeFrame: 1 hours
measure: Correlation of the percentage of heart fat with miRNA´s in diabetic patients
timeFrame: 1 hour
measure: Correlation of the percentage of the content of fat in the skeletal muscle with miRNA´s in diabetic patients.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
name: Alexandra Kautzky-Willer, Univ.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klepochova R, Leutner M, Bastian M, Krebs M, Weber M, Trattnig S, Kautzky-Willer A, Krssak M. Muscle-Specific Relation of Acetylcarnitine and Intramyocellular Lipids to Chronic Hyperglycemia: A Pilot 3-T 1H MRS Study. Obesity (Silver Spring). 2020 Aug;28(8):1405-1411. doi: 10.1002/oby.22846.