louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00953355: Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
Official title: Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Anovulation
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin.

Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

Detailed description: Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms.

Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily) (experimental group, n=25) or placebo (control group, n=25) supplementation.

In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate, vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media thickness (IMT) on both common carotid arteries.

Eligibility criteria: Inclusion Criteria:

* PCOS

Exclusion Criteria:

* age \<18 or \>35 years
* BMI \>35 kg/m2
* neoplastic, metabolic, hepatic, renal, and cardiovascular disorders
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

Primary outcomes:
measure: Endothelial structure and function
timeFrame: six months
Secondary outcomes:
measure: Clinical outcome Metabolic outcome Endocrine outcome
timeFrame: six months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
References:
citation: Palomba S, Falbo A, Giallauria F, Russo T, Tolino A, Zullo F, Colao A, Orio F. Effects of metformin with or without supplementation with folate on homocysteine levels and vascular endothelium of women with polycystic ovary syndrome. Diabetes Care. 2010 Feb;33(2):246-51. doi: 10.2337/dc09-1516. Epub 2009 Nov 23.
Clinical trial NCT02860455: Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting
Official title: Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carbon Monoxide Poisoning
Keywords: CO poisoning
CO-oximetry
Pulse oximetry
Carbon monoxide saturation (SpCO)
Emergency Department
Sensitivity
Specificity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: French Society of Emergency Medicine
First posted: 2016-08-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard laboratory blood gas analysis (COHb) have reported contradictory results.

the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO poisoning, enabling rapid detection and management of patients with suspected CO poisoning in the prehospital emergency setting This study assesses the diagnostic value of pulse CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital management of patients with suspected carbon monoxide (CO) poisoning.

Detailed description: Transcutaneous SpCO will be obtained using the RAD-57 simultaneously with blood sampling for laboratory blood gas analysis, at the time of prehospital management by emergency medical services. The diagnostic performance of SpCO for the screening of CO poisoning will be determined using ROC curve analysis, and Blood COHb levels \>5% and 10% as the reference standard for CO poisonning for non-smokers and smokers respectively. Correlation between SpCO and COHb will be assessed using Bland and Altman's method.

Eligibility criteria: Inclusion criteria:

* Patient aged 18 years or older
* Patient managed by prehospital emergency medical services.
* Patient with a suspected CO exposure presenting or not with clinical signs of CO poisoning

Exclusion criteria:

* Patient for whom venous blood sampling cannot be obtained prehospitally
* Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)

Primary outcomes:
measure: SpCO optimal threshold value for detection of CO poisoning
timeFrame: Baseline
Secondary outcomes:
measure: SpCO level
timeFrame: Baseline
measure: COHb Blood carboxyhemoglobin level
timeFrame: Baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University hospital - Emergency department
Study officials:
affiliation: Montpellier University hospital - Emergency department
name: Mustapha Sebbane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01919255: Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation
Official title: Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Colonoscopy
Bowel preparation
Picolight
Clicolon
Coolprep
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-08-08
Enrollment: 236
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).

Detailed description: To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing compliance

Picolight + Coolprep \[Day-Prior\] Picolight + Clicolon \[Day-Prior\] Picolight + Coolprep \[Split-Dose\] Picolight + Clicolon \[Split-Dose\]

Eligibility criteria: Inclusion Criteria:

* 20-65 years of age
* Elective colonoscopy of outpatients(consent to the study)

Exclusion Criteria:

* Active enteritis, enteric bleeding, obstruction
* Pregnant or lactating women
* Severe liver or renal insufficiency
* Allergic to any preparation components
* History of heart disease (ischemic heart disease, congestive heart failure, arrythmia)
* History of colorectal surgery
* History abdominal surgery within 6 month
* Toxic colitis or megacolon
* Nausea or vomiting
* Status emergent abdominal surgery (ex. acute appendicitis)
* Uncontrolled clinically significant pre-existing electrolyte disturbance
* Dehydration
* Phenylketonuria
* Glucose-6-phosphate dehydrogenase deficiency
* Ileus
* Suspicious hyperphosphatemia
* Acute phosphate nephropathy

Primary outcomes:
measure: Bowel preparation quality
timeFrame: the day of colonoscopy
Secondary outcomes:
measure: Patient tolerance
timeFrame: the day of colonoscopy
Other outcomes:
measure: Adenoma detection rate
timeFrame: The day of colonoscopy
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dae Kyung Sohn
state: Gyeonggi-do
Study officials:
affiliation: NCC,Korea
name: Dae Kyung Sohn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05427955: Efficacy of Bi-level ESPB Application in Patients Undergoing VATS
Official title: Comparison of the Efficiency of Bi-Level ESPB and Single-Level ESPB for Postoperative Analgesia in Patients Undergoing VATS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Thoracic Surgery, Video-Assisted
Erector Spinae Plane Block
Multimodal Analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-40 kg/m2
* Patients undergoing elective video-assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic or opioid therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Emergency surgery

Primary outcomes:
measure: Pain scores
timeFrame: 1st hour after surgery
measure: Pain scores
timeFrame: 2nd-hour after surgery.
measure: Pain scores
timeFrame: 4th-hour after surgery.
measure: Pain scores
timeFrame: 12th-hour after surgery.
measure: Pain scores
timeFrame: 24th-hour after surgery.
measure: Pain scores
timeFrame: 48th-hour after surgery.
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Keçiören
country: Turkey
facility: Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
state: Ankara
city: Çankaya
country: Turkey
facility: Ankara City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT01425255: The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus
Official title: Prospective Exploratory Study Evaluating Sleep Quality and Sleep-Wake Patterns in Parents of Children With Type 1 Diabetes Before and Several Weeks After Initiating Using RT-CGM of Their Children.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Sleep quality
Parents
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv Medical Center
name: Sheba Medical Center
First posted: 2011-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Juvenile Diabetes Clinics

Brief summary: The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.

Detailed description: Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.

Eligibility criteria: Inclusion Criteria:

* Parents of children up to 16 years old with type 1 diabetes

Exclusion Criteria:

* Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.

Primary outcomes:
measure: sleep quality
timeFrame: 1 year
Secondary outcomes:
measure: Glycemic control
timeFrame: one year
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E. Wolfson Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Zohar Landau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391455: Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair
Official title: Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia repair
Mesh
Groin pain
Testicular pain
Lead sponsor: Chatham Kent Health Alliance
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 220
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.

Detailed description: In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of a primary unilateral inguinal hernia

Exclusion Criteria:

* Medically unfit for surgical repair

Primary outcomes:
measure: Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Number of patients with adverse events.
timeFrame: 1 year
Other outcomes:
Locations:
city: Chatham
country: Canada
facility: Chatham Kent Health Alliance
state: Ontario
Study officials:
affiliation: Chatham Kent Health Alliance
name: John A Morrison, MD;FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01162655: Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Official title: Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Cognitive-Behavioral Therapy
Internet
Telehealth
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2010-07-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.


Eligibility criteria: Inclusion Criteria:

* Must be residents of rural Manitoba (Canada)
* Must meet research diagnostic criteria for insomnia
* Must have access to a computer and high-speed internet

Exclusion Criteria:

* Comorbid conditions (medical and psychiatric) must be stable

Primary outcomes:
measure: Insomnia Severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Sleep diary data
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Maxine Holmqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmqvist M, Vincent N, Walsh K. Web- vs. telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014 Feb;15(2):187-95. doi: 10.1016/j.sleep.2013.10.013. Epub 2013 Dec 31.
Clinical trial NCT06596655: Single Use Bronchoscopes for Interventional Pulmonology
Official title: Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchoscopic Interventions
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this pilot single-arm crossover trial is to investigate the feasibility and safety of using single-use flexible bronchoscopes (SUFB) for routine diagnostic and therapeutic interventional pulmonary procedures instead of reusable flexible bronchoscopes (RFB). The main questions it aims to answer are:

Was a decision to crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) made ?

Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10) including:

1. Overall assessment
2. Scope quality
3. Scope handling
4. Scope maneuverability
5. Tool compatibility
6. Suction
7. Lavage
8. Safety
9. Image quality

Participants will undergo bronchoscopy with single use bronchoscopes.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Able to provide informed consent.

Exclusion Criteria:

1. Emergent procedure
2. Pregnancy
3. Study subjects have any diseases or conditions that interferes with safe completion of the biopsy including: cardiopulmonary instability; sensitivity to drugs that could be administered during bronchoscopy; active anticoagulation or antiplatelet therapy (warfarin, direct Xa inhibitors, thrombin inhibitors, low molecular weight heparin, unfractioned heparin, clopidogrel) not held adequately prior to the procedure; uncontrolled blood dyscrasias; concurrent pneumothorax or bullae.

Primary outcomes:
measure: Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT03587155: Study on the Mechanism of Neurodevelopment Dysplasia of Fetal Brain Caused by ASNS Gene Mutation
Official title: Study on the Mechanism of Neurodevelopment Dysplasia of Fetal Brain Caused by ASNS Gene Mutation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asparagine Synthetase Deficiency
Genetic Diseases, Inborn
Keywords: ASNS, single cell RNA seq, Neurodevelopmental Dysplasia,
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2018-07-16
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: abortive embryo or infant.

Brief summary: The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.

Detailed description: Congenital microcephaly could cause by gene mutation. Asparagine synthetase deficiency, which is caused by ASNS mutation, is a rare autosomal recessive neurometabolic disorder. It is characterized by severe developmental delay, congenital microcephaly, seizures. The investigators found a family with ASNS mutaion. The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.

Eligibility criteria: Inclusion Criteria:

* Mutation Group: Having ASNS gene mutation by DNA exon sequencing.
* Control Group: No ASNS gene mutation by DNA exon sequencing.

Exclusion Criteria:

* Mutation Group: N/A.
* Control Group: Having other gene mutation which also effect neurodevelopment.

Primary outcomes:
measure: Effect of ASNS gene mutation on RNA expression in prefrontal cortex cells of brain tissue
timeFrame: 2018.06-2020.12
Secondary outcomes:
Other outcomes:
Locations:
city: Chang Chun
country: China
facility: Bo Chen
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Bo Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: