louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06460948: Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Official title: Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Arginine Vasopressin Deficiency
Oxytocin Deficiency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model description: In this open-labeled, interventional pilot trial, 16 adults with arginine-vasopressin deficiency and 16 healthy controls balanced for age, sex, and body mass index will be recruited
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:

1. Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
2. Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.


Eligibility criteria: Inclusion Criteria:

* AVD Group:

Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement

* Healthy Control Group Adults 16-65 years old

Exclusion Criteria for all participants:

* History of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease
* Pregnancy or breastfeeding within last 8 weeks
* Any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety

Primary outcomes:
measure: Change in peripheral oxytocin concentration from 0 to 24 hours
timeFrame: Time points: time 0 min (baseline) and 24 hours
Secondary outcomes:
measure: Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls
timeFrame: From time 0 min (baseline) to 48 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01500148: St. Jude Medical Percutaneous Mitral Valve Repair Study
Official title: Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mitral Valve Prolapse
Keywords: Mitral Valve Prolapse
Mitral Valve Disease
Mitral Valve Regurgitation
Mitral Valve Insufficiency
Mitral Valve Incompetence
Percutaneous Mitral Valve Repair
Posterior leaflet prolapse
Mitral valve degeneration
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-12-28
Enrollment: 2
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: The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.

Detailed description: Subjects will be followed-up through 6 weeks post implantation.

Eligibility criteria: Inclusion Criteria:

* Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
* Subject has an ejection fraction (EF) ≥ 30%.
* Subject is of legal age (≥18 years old).
* Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.

Exclusion Criteria:

* Subject requires a complex mitral valve repair or has isolated anterior prolapse.
* Subject has mitral valve stenosis in which the annulus opening is \<10mm. Subject has valve disease other than mitral which requires surgical intervention.
* Subject requires a concomitant procedure.
* Subject has a pre-existing prosthetic valve in any position.
* Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
* Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device.
* Subject has renal insufficiency or is on chronic dialysis.
* Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
* Subject has a history of endocarditis or has active endocarditis.
* Subject has a history of autoimmune disease.
* Subject has significant known carotid artery disease.
* Subject has an aorto-mitral angle of \<110 degrees.
* Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).

Primary outcomes:
measure: Device and Procedural Success
timeFrame: During the investigational procedure
Secondary outcomes:
measure: Quantification of SAEs reported that are unique to the investigational procedure
timeFrame: Through 6 weeks post-implantation
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
Study officials:
References:
Clinical trial NCT00922948: Cryoablation Versus Radiofrequency Ablation for Small Renal Masses
Official title: A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Renal Cancers
Keywords: Radiofrequency ablation
Cryosurgery
Renal cancers
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.

Detailed description: By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.

Eligibility criteria: Inclusion Criteria:

* Patients with tumors that progress in size while on a watchful waiting protocol;
* Patients with multiple tumors;
* Patients with a tumor in a solitary kidney;
* Patients with poor renal function and a renal tumor;
* Patients with significant co-morbidities that may benefit from a less invasive approach.

Exclusion Criteria:

* Large tumors \> 4.0cm;
* Unable to have a general anesthetic;
* Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
* Uncorrectable bleeding diathesis;
* Evidence of metastatic disease.

Primary outcomes:
measure: Treatment failure rate.
timeFrame: Baseline, Weeks 6, 12, 24, 36, 48
Secondary outcomes:
measure: Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.
timeFrame: Baseline, Weeks 6, 12, 24, 36 and 48
measure: Average percentage decrease in tumor size.
timeFrame: Baseline, Weeks 6, 12, 24, 36 and 48
measure: Intra and post-operative complications rates.
timeFrame: Weeks 6, 12, 24, 36 and 48
measure: Quality of life data.
timeFrame: Baseline, Weeks 6, 12, 24, 36 and 48
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster Institute of Urology, McMaster University
name: Anil Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730548: Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
Official title: Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Tachycardia
Cardiac Desynchronization
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-08-08
Enrollment: 180
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 pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).


Eligibility criteria: Inclusion Criteria:

* Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
* Patient consents to study
* Ability to replace follow-ups with CareLink follow-ups
* Ability to attend all follow-ups at study center

Exclusion Criteria:

* Permanent AF
* Less than 18 years of age
* Life expectancy less than 15 months
* Participation in another clinical study
* Pregnancy

Primary outcomes:
measure: Time to first hospitalization due to worsened heart failure
timeFrame: 15 months
Secondary outcomes:
measure: Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making
timeFrame: 15 months
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: University Hospital of Goettingen
Study officials:
affiliation: University Hospital of Goettingen
name: Markus Zabel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zabel M, Vollmann D, Luthje L, Seegers J, Sohns C, Zenker D, Hasenfuss G. Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study. Contemp Clin Trials. 2013 Jan;34(1):109-16. doi: 10.1016/j.cct.2012.10.001. Epub 2012 Oct 13.
citation: Luthje L, Vollmann D, Seegers J, Sohns C, Hasenfuss G, Zabel M. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Europace. 2015 Aug;17(8):1276-81. doi: 10.1093/europace/euv039. Epub 2015 May 17.
Clinical trial NCT03179748: Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients
Official title: Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are haemophilia A patients who based on the indication will benefit from treatment with turoctocog alfa. No limitation has been set to the severity of haemophilia A, gender, age, previously treated and untreated patients.

Brief summary: The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico


Eligibility criteria: Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Male and female patients with haemophilia A
* Age range is 0 years and above
* The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Known or suspected allergy to turoctocog alfa or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Primary outcomes:
measure: Frequency of adverse reactions
timeFrame: 3-36 months after enrollment
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 3-36 months after enrollment
measure: Efficacy in treatment of bleeds
timeFrame: 3-36 months after enrollment
measure: Consumption of turoctocog alfa for prophylaxis
timeFrame: 3-36 months after enrollment
measure: Consumption of turoctocog alfa for treatment of bleeds
timeFrame: 3-36 months after enrollment
measure: Consumption of turoctocog alfa for surgery and post-surgical period
timeFrame: 3-36 months after enrollment
measure: Number of patients with confirmed inhibitors
timeFrame: 3-36 months after enrollment
measure: Number of patients with allergic/hypersensitivity reactions to turoctocog alfa
timeFrame: 3-36 months after enrollment
measure: Number of bleeding episodes
timeFrame: 3-36 months after enrollment
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
Study officials:
References:
Clinical trial NCT02363348: Efficacy and Safety of L Arginine to Prevent Preeclampsia
Official title: Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preeclampsia
Keywords: L arginine
Preeclampsia
Lead sponsor: Hospital Civil Juan I. Menchaca
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.

applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes

Detailed description: Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.

Each three weeks were evaluated in search of high blood pressure and proteinuria.

The follow-up was until the end of pregnancy and two weeks after this

Eligibility criteria: Inclusion Criteria:

* one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)

Exclusion Criteria:

* pregnant women carriers of chronic renal failure
* pre gestational diabetes
* multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)

Primary outcomes:
measure: efficacy of L arginine to prevent preeclampsia
timeFrame: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
Secondary outcomes:
measure: perinatal outcome
timeFrame: from time to delivery until two weeks after, approximalety 18 weeks
measure: safety of L arginine
timeFrame: from time of randomization until birth approximalety 18 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Panduro Baron J Guadalupe
state: Jalisco
Study officials:
affiliation: Hospital Civil Juan I. Menchaca
name: Guadalupe Panduro, Ph
role: STUDY_CHAIR
References:
citation: Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.
citation: Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G, Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.
Clinical trial NCT01756248: EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan
Official title: Special Drug Use Investigation of EYLEA for AMD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: EYLEA
Age-Related Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-12-25
Enrollment: 3872
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subfovear choroidal neovascular age-related macular degeneration

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD).

The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice.

A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.


Eligibility criteria: Inclusion Criteria:

* Patients who received EYLEA for AMD

Exclusion Criteria:

* Patients who have already received EYLEA

Primary outcomes:
measure: Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA
timeFrame: Up to 3 years
measure: Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA
timeFrame: Up to 3 years
measure: Mean changes in visual acuity
timeFrame: Baseline and 6, 24 or 36 months
measure: Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline)
timeFrame: Up to 3 years
measure: Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments
timeFrame: Baseline and 6, 24 or 36 months
measure: Number and intervals of ITV injection of EYLEA
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02154048: Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery
Official title: Analgesic Efficacy of Perineural Dexamethasone Added to Ropivacaine 0.5% With 1:400,000 Epinephrine During Single-injection Supraclavicular Block for Outpatient Hand Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Surgery, Hand
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 5
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: The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.

Detailed description: The goal for pain control after surgery is to provide the best possible pain control for the longest period of time with the least amount of side effects. One type of pain medication is called local anesthetic, which is a numbing medication that is injected in the area surrounding nerves to block pain. This injection is called a nerve block. Ropivacaine is a local anesthetic that is commonly used for nerve blocks and will be used in this study. The effects of ropivacaine may last for 8 to 12 hours after surgery. Recent research studies have shown that adding a medication called dexamethasone (a steroid) may increase the time that the nerve block will provide pain control. The purpose of this study is to see if adding dexamethasone to ropivacaine and injecting this around the nerves during a supraclavicular brachial plexus block increases the duration of pain relief as compared to both placebo control and systemic control groups.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age and older
* Patients scheduled for elective outpatient hand surgery with same day discharge at the Duke Ambulatory Surgery Center

Exclusion Criteria:

* Patients who refuse regional anesthesia
* Patients in whom peripheral nerve block is contraindicated
* Patients unable to sign/understand consent
* Patients with significant language barriers who cannot comply with data collection process
* Patients with known allergies to local anesthetics
* Pregnancy
* Chronic pain patients or patients requiring chronic opioid treatment
* Patients with a history of diabetes
* Patients with contraindication to steroid administration (allergy, chronic steroid use)

Primary outcomes:
measure: Time to First Analgesic Dose
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Stephen Melton, MD
role: PRINCIPAL_INVESTIGATOR
References: