louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01322113: Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder
Official title: Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BIPOLAR DISORDER
Keywords: BIPOLAR
MANIA
DEPRESSION
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALL BIPOLAR PATIENTS IN THE HADASSAH MEDICAL ORGANIZATION PSYCHIATRIC OUTPATIENTS CLINIC

Brief summary: This study deals with the possible molecular mechanisms that underlie the etiology of bipolar disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like compounds (DLC) in the depressive state of this disease. The possibility, however, that they are also involved in the manic phase of the disease was never addressed. The results of this study may have significant implications for the treatment of BD by DLC derivatives.

Detailed description: Depressive symptoms are the hallmark major depressive disorder, dysthymia and bipolar depression within the context of bipolar disorder (BD). They share clinical characteristics including depressed mood, anhedonia, and low energy and require medical treatment. The Na+, K+-ATPase is a major transporter in the plasma membrane which has an important role in regulating cell volume, cytoplasmic pH and Ca++ levels. Digitalis-like compounds (DLC); steroids identified as normal constituents of human brain, plasma and other tissues, exclusively interact with the Na+, K+-ATPase and induce numerous biological effects. We raised the hypothesis that Na+, K+-ATPase/DLC system is involved in BD based on studies from ours and other laboratories, which tested the involvement of this system in the depressive state of BD. The possibility that the interaction of DLC with the Na+, K+-ATPase is involved in the manic state of BD was scarcely investigated. To address this issue we intend to determine circulating DLC levels in patients with BD at different states of the disease;

Eligibility criteria: Inclusion Criteria:

* BIPOLAR DISORDER PATIENTS

Exclusion Criteria:

* NONE

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: RENA COOPER-KAZAZ, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03562013: Family Experience of Home Opioid Use After Pediatric Surgery
Official title: Family Experience of Home Opioid Use After Pediatric Surgery: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Management
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 89
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any child (0-18 years) who has undergone a surgical procedure at The Hospital for Sick Children within 7 days of discharge.

Brief summary: A systematic review examining outpatient opioid use identified only three pediatric studies published between 2015 and 2016. Of these three, two studies had a short-term follow up with patients at three days after discharge; moreover, these three studies were limited by focusing on one surgical population, restriction of data to 0-12 yr old participants, and the other being a brief report. As a result, there are no pediatric studies that have examined opioid use amongst 0-18 yr olds, across multiple surgery types, and beyond 3 days after discharge.

Detailed description: This study is being done to learn how long children (0-18 yrs) needed to use the prescribed opioid medication for and how families can be better prepared to provide adequate and safe pain management at home. Follow up will take place 28 days after discharge from the hospital.

Eligibility criteria: Inclusion Criteria:

* Families are filling a prescription for opioid medications at Shoppers Drug Mart at The Hospital for Sick Children
* Parent has strong command of the English language (i.e., no interpreter required)

Exclusion Criteria:

* Child has used opioid medication at home within 6 months before the date of their surgical procedure
* Child has history of chronic pain
* Child is being discharged to a rehabilitation facility anticipated

Primary outcomes:
measure: Questionnaire on Opioid use
timeFrame: 28 days following discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Staff Anesthesiologist
name: Conor Mc Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591.
citation: Caldeira-Kulbakas M, Stratton C, Roy R, Bordman W, Mc Donnell C. A prospective observational study of pediatric opioid prescribing at postoperative discharge: how much is actually used? Can J Anaesth. 2020 Jul;67(7):866-876. doi: 10.1007/s12630-020-01616-5. Epub 2020 Mar 12.
Clinical trial NCT02665013: Reducing Delay of Vaccination in Children Study
Official title: Reducing Delay of Vaccination in Children Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communicable Diseases
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: University of Michigan
First posted: 2016-01-27
Enrollment: 824
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.

Detailed description: This intervention is based on the concept of "message tailoring," whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. Message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations.

In this three-armed trial the investigator will examine how providing mothers with multiple "doses" of a tailored versus untailored version of our intervention compares with "usual care" for the impact on infant under-vaccination. Secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.

Eligibility criteria: Inclusion Criteria:

* Enrolled at Kaiser Permanente Colorado, Pregnant in the 3rd trimester, and plan to use Kaiser Permanente Colorado for the child's medical care received.

Exclusion Criteria:

* less then 18 years of age, non-english speaking and an inability to consent

Primary outcomes:
measure: The child's vaccination status
timeFrame: 200 days
Secondary outcomes:
measure: Maternal Vaccine attitudes
timeFrame: 12 months
measure: Maternal Vaccine values
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
Study officials:
References:
citation: Glanz JM, Wagner NM, Narwaney KJ, Pyrzanowski J, Kwan BM, Sevick C, Resnicow K, Dempsey AF. Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial. Pediatrics. 2020 Nov;146(5):e20200669. doi: 10.1542/peds.2020-0669. Epub 2020 Oct 12.
citation: Dempsey AF, Wagner N, Narwaney K, Pyrzanowski J, Kwan BM, Kraus C, Gleason K, Resnicow K, Sevick C, Cataldi J, Brewer SE, Glanz JM. 'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination. BMJ Open. 2019 May 22;9(5):e027968. doi: 10.1136/bmjopen-2018-027968.
Clinical trial NCT04361513: Genicular Nerve Block in Rheuamtoid Arthritis
Official title: Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Joint Function Disorder
Inflammation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group received nerve block and another group received steroid
Primary purpose: TREATMENT

Brief summary: N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.


Eligibility criteria: Inclusion Criteria:

* RA patients
* Age \> 18
* unilateral persistent knee arthritis

Exclusion Criteria:

* Participants with severe knee osteoarthritis
* peripheral neuropathy
* psoriatic arthritis
* skin infection
* or those who have allergy for Bupivacaine

Primary outcomes:
measure: Pain changes by VAS
timeFrame: at 0 time after 2 weeks and after 12 weeks
measure: SOLAR score for inflammation changes by ultrasound
timeFrame: at 0 time after 2 weeks and after 12 weeks
measure: Lysholm score for change in knee function
timeFrame: at 0 time after 2 weeks and after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
References:
Clinical trial NCT03589313: Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
Official title: Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2018-07-17
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.


Eligibility criteria: Inclusion Criteria:

* Male subject ≥18 years of age on the day of signing the ICF.
* A confirmed clinical diagnosis of CF.
* Exocrine pancreatic insufficiency (documented in the subject's medical record).
* Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration

Exclusion Criteria:

* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
* Need for supplemental oxygen during the day, and \>2 L/minute while sleeping.
* History of solid organ or hematopoietic cell transplantation.
* History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).
* Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
* Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.

Primary outcomes:
measure: Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
timeFrame: Between Day 1 pre-dose and Day 4.
measure: Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
timeFrame: Between Day 1 pre-dose and Day 4.
measure: Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
timeFrame: Between Day 1 pre-dose and Day 4.
Secondary outcomes:
measure: The number of subjects with adverse events.
timeFrame: From screening to 19 days after the last dose.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven,Pediatric Pulmonology
Study officials:
affiliation: Galapagos NV
name: Olivier Van de Steen, MD MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03884413: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France
Official title: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Keywords: breast cancer survivors,
spontaneous fertility rates,
pregnancy,
birth rate,
chemotherapy-induced infertility
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: seintinelles network
First posted: 2019-03-21
Enrollment: 1004
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with previous diagnosis of breast cancer and time from diagnosis comprised between one and five years

Brief summary: FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

Detailed description: Breast cancer is the most common cancer among women. With the increase of the survival rates, a growing attention is paid to the side effects of the treatments, particularly chemotherapy-induced infertility.

The FEERIC study will give insights into spontaneous fertility outcomes following breast cancer in comparison with a control cohort and will provide data to help patients counselling towards spontaneous fertility rates following breast cancer. It will also provide data on contraceptive prevalence and unintended pregnancy rates in French breast cancer survivors. Reasons for unmet need for family planning will be deciphered, in order to point out pitfalls (lack of patient's information or orientation/ignorance of contraception methods available/topic insufficiently or not discussed with the physician/ lack of family planning offer etc...); and target the appropriate actions to lead (oncologist and oncology nurses education/ dedicated consultations in breast cancer centers/etc...).

Eligibility criteria: Inclusion Criteria:

* females aged from 18 to 43 at inclusion
* previous diagnosis of breast cancer and time from diagnosis comprised between one and five years or women free from breast cancer or other malignancy (healthy volunteers) .

Exclusion Criteria:

* hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
* healthy volonteer with history of malignant disease.

Primary outcomes:
measure: Spontaneous pregnancies between cases and controls
timeFrame: 3 years
Secondary outcomes:
measure: Time to spontaneous pregnancy
timeFrame: 3 years
measure: Contraceptive prevalence
timeFrame: 3 years
measure: Rate of women considered with risk of unintended pregnancy
timeFrame: 3 years
measure: Percentage of live births obtained by medically assisted procreation procedures
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Seintinelles.Com
Study officials:
affiliation: Institut Curie
name: Anne-Sophie HAMY-PETIT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05569213: Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP)
Official title: Combining Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP) to Map Activation Loci in the Human Corticospinal Tract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MEP Onset Latency
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient population will be those diagnosed with medically refractory Parkinson's Disease or Essential tremor and scheduled for DBS surgery.

Brief summary: MEP onset latencies from the hand muscle using two different stimulus methods will be compared from each study participant. Conventional MEP data will be collected prior to skin incision. Following the DBS insertion hand muscle evoked responses will be generated via the DBS electrode. A hand held DBS programmer will be connected to the proximal end of the implanted DBS for delivery of electrical stimuli. Stimulus intensity will be adjusted until a hand muscle evoked potential is registered from the same recording electrodes used for the conventional MEP acquisition. A STN-implanted electrode can produce hand muscle responses due to it's close proximity to the motor fibres of the internal capsule. When the conventional and DBS-induced hand muscle responses have been acquired the study data objectives have been met. Data will be analyzed off-line.

Detailed description: Purpose: Hand muscle MEP generated via the DBS electrode will provide an onset latency standard from which we can compare conventional MEP from the same hand muscles. It is critical for validation of conventional MEP to know where in the brain the motor pathway is being stimulated. This will avoid false negative MEP test results.

Objectives: We will measure the onset latencies from hand muscle MEP generated via the DBS electrode as well as using conventional MEP methods. The DBS onset latency data will provide a known anatomical standard to compare with conventional hand MEP.

Eligibility criteria: Inclusion Criteria:

* Male or female patients scheduled for DBS surgery under general anesthesia; age 35-75 years; no history of stroke or peripheral nerve disease

Exclusion Criteria:

* peripheral nerve disease (e.g. type I diabetes); demyelinating disease (e.g. multiple sclerosis); previous stroke; allergy to propofol based anesthesia

Primary outcomes:
measure: Combining deep brain stimulation (DBS) and motor evoked potentials (MEP) to map activation loci in the human corticospinal tract
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Marshall F Wilkinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544713: Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery


Eligibility criteria: Inclusion Criteria:

* Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Exclusion Criteria:

* Dry eye signs and symptoms
* Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
* Pregnancy or planning pregnancy
* Uncontrolled systemic disease
* Use of systemic medications affecting dry eye

Primary outcomes:
measure: Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
timeFrame: Day 90
Secondary outcomes:
measure: Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
timeFrame: Day 90
measure: Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
timeFrame: Day 90
measure: Best Corrected Visual Acuity (BCVA) Status at Day 90
timeFrame: Day 90
measure: Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
timeFrame: Baseline, Day 90
measure: Change From Baseline in Study Product Usage at Day 90
timeFrame: Baseline, Day 90
Other outcomes:
measure: Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
timeFrame: Day 14, Day 60
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: