louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00572819: Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial
Official title: Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Ripening
Keywords: Hysteroscopy
Misoprostol
Postmenopausal women
Cervical ripening
Dilatation
Sequential trial
Estradiol
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Nord
First posted: 2007-12-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* All postmenopausal (\> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment

Exclusion Criteria:

* Women who do not wish to participate
* Women who are medically unfit for hysteroscopy
* Women who are medically unfit for participation in any clinical trial
* Women who do not have a medical indication for hysteroscopy
* Women who have previously had, or currently have breast or gynaecological cancer
* Women who have a medical contraindication for locally applied oestradiol
* Women who are currently using hormone therapy
* Women who are unable to communicate in Norwegian, and
* Women with a known allergy to misoprostol

Primary outcomes:
measure: The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.
timeFrame: 24 hours
Secondary outcomes:
measure: Difference between baseline cervical dilatation at recruitment and preoperative dilatation.
timeFrame: 14 days
measure: Women with cervical dilatation ≥ 5 mm.
timeFrame: 14 days
measure: Acceptability.
timeFrame: 14 days
measure: Number of dilatations judged as "difficult."
timeFrame: 14 days
measure: Frequency of complications.
timeFrame: 14 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Gynaecological Department, Ullevål University Hospital
Study officials:
affiliation: University of Oslo
name: Britt-Ingjerd Nesheim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03389919: Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT
Official title: EFFECTIVENESS AND SAFETY OF INTRAOSSEOUS ADMINISTRATION OF MESENCHYMAL STORMAL CELLS FOR PRIMARY GRAFT FAILURE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mesenchymal Stem Cell Transplantation
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2018-01-04
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: TREATMENT

Brief summary: Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow niches for hematopoietic stem cells. Donor MSCs can serve as a source of recovery for niches in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation. Since only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac spine. Preliminary results suggest that MSCs participate in the restoration of niches for donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection of the graft. Perhaps intraosseous implantation of MSCs contributes to the success of the second transplantation of hematopoietic stem cells and patient survival.


Eligibility criteria: Inclusion Criteria:

* All patients with primary graft failure after allo-HSCT
* Available MSC for this patient

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Engraftment
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: BMT department
Study officials:
References:
Clinical trial NCT02975219: Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis
Official title: Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.


Eligibility criteria: Inclusion Criteria:

1. Females aged ≥ 18 years
2. Scheduled for surgery for the treatment of endometriosis
3. WHO performance score of 0-2
4. Written informed consent

   For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
5. A negative serum pregnancy test prior to receiving the tracer
6. Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.

Exclusion Criteria:

1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
2. Pregnancy
3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
4. Significant renal, cardiac, or pulmonary disease (ASA III-IV)

Primary outcomes:
measure: Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology
timeFrame: within 6 months after surgery
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: within two weeks after tracer injection
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMCG
name: Gooitzen van Dam, prof dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00332319: Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
Official title: See Detailed Description
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Incontinence, Urinary and Urinary Bladder, Overactive
Overactive Bladder
Keywords: spinal cord injury
urgency
Overactive bladder
neurogenic
neurometry
frequency
urge incontinence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a two-part study in which Part A will assess the effects of GW679769 after 1 dose on the function of the nerves that supply the bladder. The technique for measuring the nerves function is called Neurometry. Part B will assess the effect of repeat doses of GW679769 on the bladder nerve function. Part B will also assess the effects of the drug on overactive bladder symptoms using a three-day patient diary.

Detailed description: A randomized, double-blind, placebo-controlled study to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single 150 mg dose (Part A) and to evaluate the effect of CPT and symptoms of overactive bladder following 28 days of repeat dosing with 120 mg GW679769 administered once daily (Part B) in patients with neurogenic bladder due to incomplete spinal cord injury

Eligibility criteria: Inclusion criteria:

* Spinal cord injury patients with overactive bladder symptoms including urge incontinence, urgency, frequency and night-time urination but without bladder related pain.
* The injury must be above S1-3

Exclusion criteria:

* Spinal cord injury suffered within 6 months.
* History of interstitial cystitis, radiation cystitis, pelvic irradiation, or myocardial infarction with 1 year prior to screening.
* Pregnant or nursing females.
* Patients who have had hypersensitivity to lidocaine.
* Patients who are taking oral corticosteroids.
* Patients with active peptic ulcer disease (PUD) and/or history of PUD of an unknown etiology.

Primary outcomes:
measure: Change in bladder nerve activity assessed by neurometry before and after a single dose of GW679769 and placebo (part A) and after 28 days of drug or placebo treatment (part B).
Secondary outcomes:
measure: Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes).
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01104519: A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)
Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Multiple Oral Doses of 2000 mg of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity in Subjects With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.


Eligibility criteria: Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate methods of contraception throughout the study
* Subject is in good health (other than history of high cholesterol)
* Subject is a non-smoker

Exclusion Criteria:

* Subject has a history of stroke, seizures or major neurological disorder
* Subject has a history of cancer
* Subject is unable to refrain from or anticipates the use any prescription or non-prescription drugs
* Subjects consumes excessive amounts of alcohol or caffeine

Primary outcomes:
measure: flow-mediated dilation (FMD) of brachial artery
timeFrame: predose, 4 hours post dose and 24 and hours post dose
measure: Nitroglycerin (GTN) induced dilation of brachial artery
timeFrame: predose, 4 hours post dose and 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00037219: The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
Official title: A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis
Keywords: Anidulafungin
Candidemia
Invasive Candidiasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Vicuron Pharmaceuticals
First posted: 2002-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.


Eligibility criteria: Inclusion Criteria:

* Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
* Life expectancy: greater than 72 hours

Exclusion Criteria:

* Pregnant Females
* Treatment with other investigational drug(s) within 4 weeks
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: King of Prussia
country: United States
facility: Versicor, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01943019: Linagliptin in Schizophrenia Patients
Official title: A Pilot Study to Assess the Efficacy of Linagliptin as an Adjunct in Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Universiti Kebangsaan Malaysia Medical Centre
First posted: 2013-09-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Approximately one third of patients with schizophrenia show a poor response to standard treatment with antipsychotic medications. This treatment resistant group of patients represents a major challenge in everyday psychiatry, and consumes a disproportionate amount of time from the clinicians, resulting in considerable costs to the society and government. Anecdotal evidence suggests that the enzyme dipeptidyl peptidase IV (DPPIV) may be altered in patients with schizophrenia, with a higher level DPPIV enzyme activity being noted. We postulate that this may play a role in the neuropathology of schizophrenia patients and by inhibiting the DPPIV enzyme activity with a DPPIV inhibitor such as linagliptin, we will be able to improve and even ameliorate the symptoms of schizophrenic patients. However, until now there have yet any studies on the potential of these inhibitors in schizophrenia patients. A pilot study is thus proposed to evaluate the potential of the DPPIV inhibitor, linagliptin as an adjunct in schizophrenia patients who are non-responsive to treatment, which will establish the feasibility of a larger trial.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and above
* Diagnosis of schizophrenia.
* Clinically stable antipsychotic regimen for the last 3 months
* A total score of 80 or greater at baseline on the Positive and Negative Syndrome Scale
* Competent and willing to provide written, informed consent

Exclusion Criteria:

* History of substance dependence within the past 2 months
* Existing relevant physical health problems: such as uncontrolled cardiovascular disease and impaired liver/ renal function
* History of diabetes
* History of hepatic or biliary diseases / biliary obstruction
* A serious suicide/homicide risk in the opinion of the investigator
* Known allergy to linagliptin

Primary outcomes:
measure: PANSS Score
timeFrame: 3 months
Secondary outcomes:
measure: Drug safety
timeFrame: 3 months
Other outcomes:
measure: DPP-4 enzyme levels
timeFrame: 3 months
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
affiliation: Pusat Perubatan UKM
name: Maniam Thambu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01085019: Impact of Spices and Herbs on Endothelial Function
Official title: Investigation of the Impact of Spices and Herbs on Endothelial Function and Other CVD Risk Factors in Men and Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Keywords: Endothelial function
Cardiovascular risk factors
Spices
Herbs
Antioxidant
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: McCormick Canada Co
First posted: 2010-03-11
Enrollment: 224
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The general objective of the study is to investigate the effects of the daily consumption of spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular risk factors of men and postmenopausal women.

Detailed description: The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.

Eligibility criteria: Inclusion Criteria:

* Age 40-70 yrs
* Men and postmenopausal women
* Waist girth \>102cm (men) or \>88cm (women)
* LDL-C \> 2.8 mmol/L
* Framingham 10-yr risk score \< 10%
* Marginal endothelial dysfunction
* Non smoker

Exclusion Criteria:

* Medication for lipid, hypertension, diabetes
* History of CVD, diabetes, other endocrines disorders
* Pre-menopausal women
* Alcohol consumption \> 1 drink per day
* Unusual dietary habits (e.g. vegetarism)
* Chronic use of supplements (estrogens, vitamins, minerals or flavonoids)
* Aversion or intolerance for spices and/or herbs
* Injury to fingers or amrs that would interfere with endothelial function measurement

Primary outcomes:
measure: Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone)
timeFrame: at week 0 and week 4
Secondary outcomes:
measure: Circulating level of plasma lipoproteins-lipids
timeFrame: at week 0 and week 4
measure: Oxidative stress
timeFrame: at week 0 and week 4
measure: Endothelial activation and inflammatory markers
timeFrame: at week 0 and week 4
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre of Functional Foods and Nutracuticals
state: Manitoba
city: Quebec City
country: Canada
facility: Institute of Nutraceuticals and Functional Foods
state: Quebec
Study officials:
affiliation: Laval University
name: Charles Couillard, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carnovale V, Paradis ME, Gigleux I, Ramprasath VR, Couture P, Jones PJ, Lamarche B, Couillard C. Correlates of reactive hyperemic index in men and postmenopausal women. Vasc Med. 2013 Dec;18(6):340-6. doi: 10.1177/1358863X13507975.
Clinical trial NCT06938919: Electronic Respiratory Sound Monitoring System in Gastrointestinal Endoscopic Sedation
Official title: Impact of Implementing an Electronic Respiratory Sound Monitoring System for Quality Improvement in Gastrointestinal Endoscopic Sedation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastrointestinal Endoscope
Endoscopic Retrograde Cholangiopancreatogram (ERCP)
Keywords: Electronic repiratory sound monitoring system
Gstrointestinal endoscopic sedation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the application of an electronic respiratory sound monitoring system during sedation for gastrointestinal endoscopy and to determine its effectiveness in improving sedation quality. Gastrointestinal endoscopy is a common medical procedure, but respiratory complications caused by sedation, such as hypoventilation and airway obstruction, are significant safety concerns. Traditional respiratory monitoring methods, such as end-tidal CO2 monitoring, are often unreliable due to difficulties in gas sampling during the procedure. In contrast, an electronic respiratory sound monitoring system can accurately capture tracheal breathing sounds and provide important parameters such as respiratory rate and airway obstruction ratio, helping clinicians avoid over-sedation. This study will conduct a randomized controlled trial with 120 participants, divided into a control group with conventional monitoring and an experimental group using the electronic respiratory sound monitoring system. The study will compare sedation dosage, airway complications, and recovery speed between the two groups, and further analyze the clinical value of the system's parameters. The findings of this study will contribute to improving the safety and precision of sedation during gastrointestinal endoscopy and provide evidence for future clinical guidelines.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo routine colonoscopy plus gastroscopy or endoscopic retrograde cholangiopancreatography (ERCP) and require deep sedation

Exclusion Criteria:

* Pregnancy
* Patients diagnosed with sleep apnea or morbid obesity (BMI greater than 40 kg/m2)

Primary outcomes:
measure: Desaturation
timeFrame: during the procedure
Secondary outcomes:
measure: Incidence of airway management for desaturation
timeFrame: during the procedure
measure: Total amount of anesthetics
timeFrame: during the procedure
Other outcomes:
measure: QoR-15 Questionnaire
timeFrame: 24hrs
Locations:
Study officials:
affiliation: Department of Anesthesiology, National Taiwan University Hospital
name: Kuang-Cheng Chan, M.D.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: