louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01115959: Seizures Post Intracerebral Hemorrhage
Official title: Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Cerebral Hemorrhage
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-05-04
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.


Eligibility criteria: Inclusion Criteria:

* cerebral hemorrhage spontaneous

Exclusion Criteria:

* early seizures

Primary outcomes:
measure: number of seizures
timeFrame: study drug for 1 month and 1 year follow up
Secondary outcomes:
measure: neurological outcome NIHSS
timeFrame: during 1 month study drug and 1 year post follow up
Other outcomes:
Locations:
Study officials:
affiliation: E Wolfson med center
name: ronit gilad, md
role: PRINCIPAL_INVESTIGATOR
affiliation: E wofson med center
name: ronit gilad, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401659: Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrythmia
Keywords: remote monitoring
satisfaction
telemonitoring
quality of life
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 187
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: Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.

Brief summary: Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.


Eligibility criteria: Inclusion Criteria:

1. Patients- naïve in CareLink®:

   * First implant patients, who initiate in CareLink®
   * Replacements patients who initiate in CareLink.
2. Long term users in CareLink®: patients in CareLink for more than a year.
3. Both male and female
4. More than 18 years old.
5. Be at the disposal of using CareLink monitoring system.
6. Complete informed consent and accept the conditions of CareLink system.

Exclusion Criteria:

1. Less than 18 years old
2. Suffer from any menthal pathology who prevents the patient to collaborate in the study.
3. Be unable to understand or answer questionnaires in Spanish.
4. Deny to continue in the study.

Primary outcomes:
measure: Satisfaction with telemedicine measured by the questionnaire in evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Satisfaction with medical treatment measured by visual analog scale
timeFrame: 12 months
measure: Quality of Life measured by SF-36
timeFrame: 12 months
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital Universitario de Araba
state: Basque Country
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
state: Catalonia
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
Clinical trial NCT04395859: Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents
Official title: Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Keywords: Intravitreal Injections
Anti-angiogenics
COVID19
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-05-20
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with repeated IVT treatment of anti-angiogenic drugs

Brief summary: In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months.

The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.


Eligibility criteria: Inclusion Criteria:

* Ocular pathology requiring repeated IVT treatment of anti-angiogenic drugs (exudative AMD, diabetic macular edema or secondary to retinal venous occlusion ...)
* Beginning of IVT treatment repeated before 10/01/2019 (6 months before the start of French confinement)

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic
timeFrame: Baseline (Before confinement) and 6 months after resumption of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ecully
country: France
facility: Centre Pôle Vision du val d'Ouest
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
city: Paris
country: France
facility: Hôpital Lariboisière
city: Strasbourg
country: France
facility: Centre ophtalmologique Maison Rouge
Study officials:
affiliation: Fondation Adolphe de Rothschild
name: Martine MAUGET FAYSSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03994159: Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit
Official title: Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit Specialized in Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout, Professional
Stress
Anxiety
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Chateau du Loir
name: Centre Hospitalier de Saint Calais
name: Centre Hospitalier Local de Beaumont sur Sarthe
First posted: 2019-06-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi experimental before-after study, with a mixed qualitative and quantitative approach.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Since February 2016, with the objective of improving the quality of life and the autonomy of residents, the Le Mans General Hospital uses an interactive "emotional" robot within its geriatric wards.

This emotional robot, Paro, is equipped with a dozen sensors, 3 microphones and interacts with its user: it reacts to touch, voice and heat making small sounds and moves its head, fins and tail. The algorithm that governs Paro's behavior allows him to offer a behavioral answer adapted to the user's stimuli. Thus, Paro is able to communicate beneficial emotions to patients.

To this day however there is no published study exploring the effect of such a robot on team dynamics among caregivers in hospital units.

Our research aims at highlighting the benefits that a healthcare team perceives when working with this tool among patients suffering from dementia.


Eligibility criteria: Inclusion Criteria:

* Non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards.

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients
timeFrame: 1 month
Secondary outcomes:
measure: Impact of PARO on the caregivers perception of their own health.
timeFrame: 1 month
measure: Impact of PARO on the caregivers perception of their own stress at work.
timeFrame: 1 month
measure: Impact of PARO on the caregivers perception of their own anxiety at work.
timeFrame: 1 month
Other outcomes:
Locations:
city: Beaumont sur Sarthe
country: France
facility: Centre Hospitalier Local Beaumont sur Sarthe
Study officials:
affiliation: Centre Hospitalier du Mans
name: Cathy LOIRAT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02782559: Efficacy of Sildenafil in Preterm Preeclampsia
Official title: Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Preterm Preeclampsia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia

Detailed description: Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks.
2. Dating of pregnancy by ultrasound \< or equal to 22 weeks or IVF conception
3. Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia

Exclusion Criteria:

1. Need for immediate delivery of the fetus
2. Known lethal anomaly
3. Pre-existing renal disease
4. Hypersensitivity to sildenafil
5. Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs
6. Active peptic ulcer disease
7. Undergoing nitrate therapy

Primary outcomes:
measure: Latency (duration of pregnancy from diagnosis/randomization until delivery)
timeFrame: Diagnosis (randomization) until delivery, up to 34 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Robyn P Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805959: Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System
Official title: Colonic Motility in Constipation and Aging: A Pilot Study With a New 3D Transit System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Women with constipation

Brief summary: To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.


Eligibility criteria: Inclusion Criteria:

* Constipation

Exclusion Criteria:

* Constipation caused by other disease

Primary outcomes:
measure: Transit time through the small intestine and the colon. Both the total transit time, the regional transit times and the antegrade and retrograde movements are measured by the MTS system
timeFrame: The total transit time will differ between healthy and constipated but probably between 3-5 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04406259: Atrioventricular Block and Cluster Headache (SEVA)
Official title: Atrioventricular Block and Cluster Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cluster Headache
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort, interventional , multicentric study
Primary purpose: OTHER

Brief summary: Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.


Eligibility criteria: Inclusion Criteria:

* patient 18 years old, and older
* patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias)
* patients affiliated to the social security
* patient that has given his full written consent to participate in the study
* female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study

Exclusion Criteria:

* patient presenting contraindications to the use of verapamil
* patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine.
* patient under justicial protection
* patient breastfeeding, or pregnant
* patient suffering from a neuromuscular transmisson disease
* patient with a pacemaker

Primary outcomes:
measure: Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
timeFrame: 27 months
Secondary outcomes:
measure: Description of the different atrioventricular conduction abnormities and their incidence
timeFrame: 27 months
measure: Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram
timeFrame: 27 months
measure: Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.
timeFrame: 27 months
Other outcomes:
Locations:
city: NICE Cedex 1
country: France
facility: CHU de Nice
state: Chun
city: Marseille
country: France
facility: AP-HP Hôpital la Timone
Study officials:
References:
Clinical trial NCT00896259: Effects of a Late Phase Exercise Program Following Total Hip Arthroplasty
Official title: Effects of a Late Phase Education and Exercise Program Following Total Hip Arthroplasty: A Pilot Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Keywords: Unilateral total hip arthroplasty
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foundation
First posted: 2009-05-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: orthopedic clinic outpatients (of one clinic)

Brief summary: A group of orthopedic physiotherapists have developed a late phase program to educate and instruct total hip replacement patients in progressive exercises appropriate for their level of recovery. The components of this program include an educational presentation, individual assessment and exercise prescription. The investigators' intent is to pilot the program using a sample of patients. The objective of this pilot project:

To examine the effects of the late phase education session and home-based exercise program in restoring hip muscle strength, gait and function


Eligibility criteria: Inclusion Criteria:

* unilateral primary total hip arthroplasty (THA)
* 8-12 weeks post THA
* over the age of 18
* able to walk 15m without a walking aid
* able to participate in an exercise program without physical assistance
* available for follow up as per the study protocol
* able to read and understand English and follow verbal and visual instructions

Exclusion Criteria:

* medically unstable
* have central or peripheral nervous system deficits
* have an underlying terminal disease (cancer)
* have suspicion of infection following joint replacement

Primary outcomes:
measure: hip muscle strength
timeFrame: 8-12 weeks post THA, 6-7 months post THA
Secondary outcomes:
measure: Gait
timeFrame: 8-12 weeks post THA, 6-7 months post THA
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Orthopedic Clinic, QEII Health Sciences Centre, CDHA
state: Nova Scotia
Study officials:
affiliation: CDHA
name: Ann Read, BScPT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04659759: COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes
Official title: COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Nemours
First posted: 2020-12-09
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum

Brief summary: This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.

Detailed description: This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COVID-19 in pregnancy or within 6 months post partum
* Planned delivery at Thomas Jefferson University Hospital

Exclusion Criteria:

* Declines routine COVID testing on admission
* In active labor/pain/otherwise unable to provide consent

Primary outcomes:
measure: Maternal COVID-19 serology (IgG and IgM)
timeFrame: 6 weeks post partum
measure: Maternal/neonatal IgG and IgM concordance
timeFrame: Delivery
measure: Maternal COVID serology time/profile following vaccination
timeFrame: 6 months
measure: Breastmilk Serology
timeFrame: 6months
Secondary outcomes:
measure: Breastmilk Serology
timeFrame: Delivery
measure: Breastmilk Serology
timeFrame: 6 weeks post partum
measure: Cytokine
timeFrame: Delivery
measure: Neonatal cytokine
timeFrame: Delivery
measure: COVID disease vs vaccination immune response
timeFrame: 6 months
measure: COVID vaccine in pregnant vs nonpregnant
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05012059: A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study
Official title: A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Daibetic Foot
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated

Brief summary: Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency.


Eligibility criteria: Inclusion Criteria:

1.Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated

Exclusion Criteria:

1. patients with prior surgical history within 1 month
2. combined operation (joint operation)
3. patients who required continuous intravenous administration of vasopressors and/or mechanical ventilation prior to surgery
4. combination of general anesthesia and PNB

Primary outcomes:
measure: Occurrence of major complication
timeFrame: Within 1 month after the surgery
measure: Occurrence of mortality
timeFrame: Within 1 month after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Hye Jin Kim
role: PRINCIPAL_INVESTIGATOR
References: