louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04160104: Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy
Official title: Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bowel Preparation
Colonoscopy
Keywords: Bowel preparation
BBPS
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective study involving two tertiary-centers in China.

Brief summary: Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. Thus, it is important to set up a model to predict the quality of bowel preparation individually.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-90 years old who undergoing colonoscopy

Exclusion Criteria:

* failed colonoscopy because of technical chanllenge or poor tolerance of patients
* history of colorectal surgery
* prior finding of severe colonic stricture or obstructing tumor
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction or ileum
* known or suspected bowel obstruction or perforation
* pregnancy
* unable to give informed consent

Primary outcomes:
measure: Boston bowel preparation quality scale
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
Study officials:
References:
Clinical trial NCT02416804: Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
Official title: Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Stenosis
Pain, Postoperative
Keywords: buprenorphine
transdermal system
Pain, postoperative
Quality of life
Spinal stenosis
Posterior lumbar fusion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the single-level posterior lumbar fusion.

After surgery, all the patients apply the patient-controlled analgesia. After three days of surgery, patients are divided into two groups.Group A is an experimental group that administer the BTDS after surgery, and Group B is a control group that take tramadol analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional rescue medicine, acetaminophen.

After the surgery, patient's pain score and quality of life would be recorded sequentially. The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months, respectively.


Eligibility criteria: Inclusion Criteria:

* adults over 20 years
* taking the lumbar spinal surgery : single-level, posterior fusion
* stay in hospital more than 2 days after operation

Exclusion Criteria:

* pregnancy or breast-feeding
* allergy or contraindication to buprenorphine
* patient with decreased lung function
* patient with taking MAO inhibitor or anticonvulsant
* patient with brain lesion, or severe liver disease
* dependence in opioid drugs
* taking muscle relaxant or tranquilizer
* patient had taken buprenorphine preoperatively
* taking strong opioids before enrolling the study
* another severe source of pain except lumbar spine
* severe cardiovascular, pulmonary, or renal compromised patients

Primary outcomes:
measure: Pain intensity score : pain NRS scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ho-Joong Kim, MD
role: STUDY_DIRECTOR
References:
citation: Kim HJ, Ahn HS, Nam Y, Chang BS, Lee CK, Yeom JS. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial. Eur Spine J. 2017 Nov;26(11):2961-2968. doi: 10.1007/s00586-017-5213-5. Epub 2017 Jul 20.
Clinical trial NCT03047304: Magnesium Effect on Embryonal PR Interval
Official title: Magnesium Effect on Embryonal PR Interval
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Labor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of gestation. High concentration of Magnesium in the blood stream known as cause of conduction abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our work is to evaluate the PR intervals in embryos after maternal treatment with magnesium during preterm labor.

Detailed description: We will recruit 25 woman with threaten preterm labor, magnesium blood level and PR interval will be evaluated before magnesium loading dose (4gr) and 20 minutes after the loading dose.

PR interval will be evaluated by Mitral-Aorta Doppler.

Eligibility criteria: Inclusion Criteria:

* Women at risk for preterm labor before 32 week of gestation

Exclusion Criteria:

* Fetal malformations
* Maternal Lupus
* Fetal conduction abnormalities

Primary outcomes:
measure: Prolonged PR interval
timeFrame: 20 min after magnesium treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Principal Investigator
name: Ola Gutzeit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gums JG. Clinical significance of magnesium: a review. Drug Intell Clin Pharm. 1987 Mar;21(3):240-6. doi: 10.1177/106002808702100301.
citation: Agus ZS, Morad M. Modulation of cardiac ion channels by magnesium. Annu Rev Physiol. 1991;53:299-307. doi: 10.1146/annurev.ph.53.030191.001503. No abstract available.
citation: Laurant P, Touyz RM. Physiological and pathophysiological role of magnesium in the cardiovascular system: implications in hypertension. J Hypertens. 2000 Sep;18(9):1177-91. doi: 10.1097/00004872-200018090-00003.
citation: Glickstein JS, Buyon J, Friedman D. Pulsed Doppler echocardiographic assessment of the fetal PR interval. Am J Cardiol. 2000 Jul 15;86(2):236-9. doi: 10.1016/s0002-9149(00)00867-5. No abstract available.
Clinical trial NCT00277004: Physiological Biomarkers of Cancer Treatment Related Fatigue in Women With Breast Cancer.
Official title: Physiological Biomarkers of Cancer Treatment Related Fatigue in Women With Breast Cancer.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast
Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females with breast cancer undergoing cancer treatment.

Brief summary: Physiological Biomarkers of Cancer Treatment Related Fatigue in Women with Breast Cancer.

Detailed description: As above.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed early stage breast cancer.

Exclusion Criteria:

* Not specified.

Primary outcomes:
measure: Disease Progression
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Ian Rabinowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04385004: Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU
Official title: Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Covid-19
SARS-CoV-2
Inflammatory cytokine
Sepsis
ICU
Tbular necrosis
Ischemia
Pulmonary damage
Renal damage
Kidney damage
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed Covid-19 by RT PCR

Brief summary: Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.

The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).

Translated with www.DeepL.com/Translator (free version)


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Diagnosed Covid-19 by RT PCR
* Hospitalized in intensive care for management of complications related to Covid-19 from March 1, 2020 to April 20, 2020
* Patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research.

Exclusion Criteria:

- Subject who expressed opposition to participating in the study

Primary outcomes:
measure: Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Reanimation Medicale
Study officials:
References:
citation: Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.
Clinical trial NCT03623204: Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity
Official title: Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Dyspnea
Bariatric Surgery
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with obesity and who underwent bariatric surgery

Brief summary: Obesity, defined as a Body Mass Index greater than or equal to 30 kg/m2, represents a significant public health issue. Dyspnea is a very common and crippling symptom in obesity. About 80% of people with obesity experience dyspnea in daily living. Bariatric surgery has been demonstrated to be an excellent treatment for obesity by inducing significant weight loss. Nevertheless, changes in dyspnea in daily living after bariatric surgery and the links between variations in dyspnea and lung function tests after bariatric surgery have not been previously investigated.

Detailed description: The objective of this study was to determine if bariatric surgery is associated with an improvement of dyspnea in daily living according to the mMRC scale in patients with obesity.

Eligibility criteria: Inclusion Criteria:

* Obesity
* scheduled bariatric surgery

Exclusion Criteria:

- age \< 18 years old

Primary outcomes:
measure: Dyspnea in daily living evaluated using the mMRC scale
timeFrame: Month 6
measure: Dyspnea in daily living evaluated using the mMRC scale
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Boissiere L, Perotin-Collard JM, Bertin E, Gaubil I, Diaz Cives A, Barbe C, Dury S, Nardi J, Lebargy F, Deslee G, Launois C. Improvement of dyspnea after bariatric surgery is associated with increased Expiratory Reserve Volume: A prospective follow-up study of 45 patients. PLoS One. 2017 Sep 20;12(9):e0185058. doi: 10.1371/journal.pone.0185058. eCollection 2017.
Clinical trial NCT06769204: Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
Official title: Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Infertility, Female
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility

Detailed description: We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women with Primary Infertility.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

Exclusion Criteria:

* Known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray.
* Current pregnancy or suspicion of pregnancy.
* Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
* Use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.

Primary outcomes:
measure: pain during Cervical instrumentation of the tenaculum and cannula
timeFrame: 1 minute
Secondary outcomes:
measure: pain At the end of uterine filling
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02832804: Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
Official title: Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .

Detailed description: * visit 1

  * to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)
  * EEG
* visit 2-6

  * tDCS stimulation (monday \~ friday)
  * anodal / cathodal / sham
  * to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
  * analysis the results of sleep log and actigraphy
* visit 7 : 1 week after treatment

  * to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
  * analysis the results of sleep log and actigraphy
  * EEG
* visit 8 : 1 month after treatment

  * to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
  * analysis the results of sleep log

Eligibility criteria: Inclusion Criteria:

* adult (older than 19 years)
* primary insomnia
* right handed
* agree with participation of this study

Exclusion Criteria:

* diagnosed with epilepsy or history of seizure
* change of antipsychotic drug within 1 month
* under suspicion of sleep apnea or periodic limb movement disorder
* mental retardation (IQ \< 70)
* pregnant woman

Primary outcomes:
measure: sleep log and actiwatch
timeFrame: Change from baseline at 1 week
Secondary outcomes:
measure: questionnaire
timeFrame: Change from baseline at 1 month
measure: EEG spectrum analysis
timeFrame: Change from baseline at 1 month
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Change from baseline at 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ki-Young Jung, professor
role: STUDY_CHAIR
References:
Clinical trial NCT05071404: Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.
Official title: Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels in Patients With Inflammatory Bowel Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 17
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inflammatory bowel disease over 14 years of age who are being treated with infliximan sc.

Brief summary: Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Detailed description: Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Treatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Patients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment.

The source of information will be the patient's medical history.

Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory bowel disease.
* Over 14 years old.
* Receive Remsin as a treatment for his disease. And always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Exclusion Criteria:

* Patients with inflammatory bowel disease under 14 years of age.
* Or older than this age with inflammatory bowel disease who do not attend the established check-ups

Primary outcomes:
measure: Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.
timeFrame: Up to 16 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Federico Arguelles Arias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05326204: 1 Versus 2 Hours Post Meal Glucose Monitoring in Gestational Diabetes on Treatment
Official title: 1 Versus 2 Hours Post Meal Self Monitoring Blood Glucose in Gestational Diabetes Mellitus on Treatment-A Prospective Randomised Controlled Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Treatment Adherence
Keywords: Gestational diabetes
treatment
glucose monitoring
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 2954
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women with gestational diabetes on treatment attending the antenatal clinic in our centre

Brief summary: A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment.

Detailed description: This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.

Eligibility criteria: Inclusion Criteria:

* Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline
* requiring treatment either with metformin alone or combined with insulin

Exclusion Criteria:

* type 1 and 2 diabetes
* bad obstetrics history
* underlying medical disorders such as Systemic Lupus Erythematosus
* fetal anomaly
* delivery elsewhere

Primary outcomes:
measure: Mode of delivery
timeFrame: from point of randomization to birth of the neonate
measure: Gestational age
timeFrame: from point of randomization to birth of the neonate
measure: Fetal weight
timeFrame: from point of randomization to birth of the neonate
Secondary outcomes:
measure: Maternal complications
timeFrame: from point of randomization to birth of the neonate
measure: perinatal complications
timeFrame: from point of randomization to birth of the neonate
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: UKM Medical Center
state: W.Persekutuan
Study officials:
affiliation: National University of Malaysia
name: Rahana Abd Rahman
role: PRINCIPAL_INVESTIGATOR
References: