louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02833038: Effect of Intravenous Magnesium During Robot Assisted Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 60
Sex: MALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effect of intravenous magnesium on blood pressure after Trendelenburg position during robot assisted prostatectomy.

The secondary purpose of this study is to investigate the effect of intravenous magnesium on pain after robot assisted prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Robot assisted prostatectomy

Exclusion Criteria:

* Allergy to magnesium
* Chronic pain
* Chronic opioid use
* Chronic NSAID use
* Renal dysfunction
* Liver dysfunction
* Cardiac arrythmia
* Seizure

Primary outcomes:
measure: Mean blood pressure
timeFrame: Up to 2 hours after Trendelenburg position
Secondary outcomes:
measure: Postoperative pain
timeFrame: Up to 24 hours after surgery end
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
citation: Kim HY, Lee SY, Lee HS, Jun BK, Choi JB, Kim JE. Beneficial Effects of Intravenous Magnesium Administration During Robotic Radical Prostatectomy: A Randomized Controlled Trial. Adv Ther. 2021 Mar;38(3):1701-1712. doi: 10.1007/s12325-021-01643-8. Epub 2021 Feb 21.
Clinical trial NCT00181038: Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery
Official title: Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery: Comparing Continuous Infusion of Local Anesthetic With Systemic Multimodal Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oropharyngeal Neoplasms
Keywords: Oro-Pharyngeal Carcinoma Surgery
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for oro-pharyngeal carcinoma surgery with reconstruction by fibula free flap

Exclusion Criteria:

* Allergy to propofol or local anesthetic (ropivacaine)
* Severe renal or cardiac failure

Primary outcomes:
measure: Assess the influence of locoregional anesthesia on postoperative morphine consumption
Secondary outcomes:
measure: Visual analog pain scale on the free flap donor site
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Frédéric Plantevin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175238: Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
Official title: Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.


Eligibility criteria: Inclusion criteria:

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogramm (ECG), and clinical laboratory tests
2. Age 18 to 50 years (incl.)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria:

1. Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and 12-lead Electrocardiogramm (ECG)) deviating from normal and judged clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 480 hours
measure: Maximum measured concentration of the analyte in plasma and whole blood (Cmax)
timeFrame: up to 480 hours
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf)
timeFrame: up to 480 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: 1334.28.01001 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01670838: Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
Official title: Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysmal Subarachnoid Heamorrhage
Nontraumatic Subarachnoid Haemorrhage
Keywords: subarachnoid haemorrhage
cardiopulmonary complications
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
First posted: 2012-08-22
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study material consists of 200 consecutive aSAH-patients treated in Kuopio University Hospital and Turku University Hospital.

Brief summary: This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.

Detailed description: Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium, potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers, remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene sample is taken once on day one.

Primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months.

Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.

Eligibility criteria: Inclusion Criteria:

* Patients with nontraumatic subarachnoid haemorrhage
* Age \> 18 years
* Aneurysmal bleeding

Exclusion Criteria:

* No consent
* Age \< 18 years
* Anticipated brain death \< 24 hours
* Otherwise moribund patient

Primary outcomes:
measure: Incidence of cardiac failure and the impact of cardiac problems on morbidity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Senior consultant, intensivist
name: Stepani Bendel, PhD, MD
role: STUDY_DIRECTOR
affiliation: Senior consultant, intensivist
name: Maarit Lång, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01087138: Study to Determine How Exercise and Calcium Affect Pubertal Bone
Official title: Effect of Exercise and Calcium Foods on Pubertal Bone Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Health
Keywords: bone health
bone density
bone mass
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 134
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine if increasing the amount of calcium that girls eat or the degree of exercise in which they participate will increase their bone strength.


Eligibility criteria: Inclusion Criteria:

* 9-10 years of age
* Premenarcheal
* Female

Exclusion Criteria:

* corticosteroid or anticonvulsant therapy
* lactose intolerance or milk allergy
* family history of hypercholesterolemia
* mental or physical handicaps
* chronic disease
* body mass index ³ 85th percentile for age and gender
* baseline calcium intake of \> 1100 mg/day
* participation in team sports \> 3 times per week

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
References:
Clinical trial NCT02979938: Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
Official title: Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zika Virus
Lead sponsor: Trinidad and Tobago IVF and Fertility Centre
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2016-12-02
Enrollment: 25
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 men aged 18-50 years with ZIKV symptoms within the preceding thirty days \& confirmed ZIKV infection (WHO criteria). The study setting is a private fertility clinic in Trinidad and Tobago - a country with a current ZIKV epidemic.

Brief summary: In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.

Detailed description: In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.

Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide evidence-based data for

1. estimating of the risk of sexual transmission of ZIKV in the general population
2. antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
3. advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
4. strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
5. advice on gamete cryopreservation
6. optimising investigations for diagnosis of ZIKV in males.

Eligibility criteria: Inclusion Criteria:

* Male aged 18-50 years
* ZIKV symptoms within the preceding thirty days
* Confirmed ZIKV infection (WHO criteria)
* Able to ejaculate to produce a semen sample

Exclusion Criteria:

• Current urological malignancy

Primary outcomes:
measure: Measurement of the presence (with RT-PCR) of ZIKV in semen
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of the viral load (with ct values) of ZIKV in semen
timeFrame: 6 months
Other outcomes:
Locations:
city: Maraval
country: Trinidad and Tobago
facility: Trinidad and Tobago IVF & Fertility Centre
Study officials:
affiliation: Trinidad & Tobago IVF & Fertility Centre
name: Catherine Minto-Bain, MB ChB MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292838: Relative Potency of Inhaled Corticosteroids
Official title: Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Eosinophilic bronchitis with asthma
Eosinophilic bronchitis without asthma
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.


Eligibility criteria: Inclusion Criteria:

* Sputum eosinophilia \>3%
* Adults age 18-70 years
* History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
* FEV1 ≥ 60% predicted
* Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
* Able to give written informed consent

Exclusion Criteria:

1. Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
2. Relevant seasonal allergen exposure within 4 weeks or within the course of the study
3. Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
4. Other respiratory diseases
5. Women who are pregnant or unwilling to use appropriate contraception during the study
6. Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Primary outcomes:
measure: Sputum eosinophils
Secondary outcomes:
measure: Exhaled nitric oxide, FEV1, FEF25-75%
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health, St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Frederick E Hargreave, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01743638: MR-Guided Laser Ablation of Prostate Bed Recurrences
Official title: Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Tumors
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.


Eligibility criteria: Inclusion Criteria:

* Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to Urology and/or Interventional Radiology for treatment.
* Surgery is not a desirable alternative therapy at the time of enrollment
* Radiation therapy has failed or not indicated or can be safely postponed
* Tumor size ≤ 5 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Performance status is ECOG 2 or better in adults
* Patient is able to undergo MRI

Exclusion Criteria:

* Patients with pacemaker or defibrillator

Primary outcomes:
measure: Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David A. Woodrum, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596838: Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser
Official title: Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracorneal Ring
Keratoconus
Laser
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated at Somain institue with the placement f intra-corneal rings using laser

Brief summary: Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.

Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.

The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus


Eligibility criteria: Inclusion Criteria:

* Patient having received the information notice/non-objection
* Adult man or woman (over 18)
* Failure of a lens fitting adaptation
* Patient with a diagnosis of keratoconus
* Patient operated at Somain institute with the placement of intra-corneal rings

Exclusion Criteria:

* Minor
* Post-lasik ectasia
* Iatrogenic Keratoconus
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Somain
country: France
facility: Institut Ophtalmique de Somain
Study officials:
References:
Clinical trial NCT00018538: Calcifidol Therapy in Men With Cancer
Official title: Calcifidol Therapy in Men With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: vitamin D
prostatic neoplasms
neoplasm recurrence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.


Eligibility criteria: Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: VAMC Miami, FL
state: Florida
Study officials:
name: Guy Howard, Ph.D
name: Gary Schwartz, Ph.D, MPH
name: James Schlesselman, Ph.D
References:
Clinical trial NCT02574338: Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Ripening and Induction of Labor
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2015-10-12
Enrollment: 135
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.

Detailed description: This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.

Eligibility criteria: Inclusion Criteria:

* Parturients who gave consent
* has low bishop score (≤5)
* term singleton cephalic presenting fetus
* intact membranes
* no contraindication to vaginal delivery

Exclusion Criteria:

* those who refused consent
* preterm delivery
* vaginal infection
* non-cephalic presentation
* multiple gestation
* low lying placenta/previa,
* vaginal bleeding,
* previous cesarean section
* rupture of membranes

Primary outcomes:
measure: Bishop Score of 6 or more
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Federal Teaching Hospital, Abakaliki
state: Ebonyi
Study officials:
References: