louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00411840: Novel Therapy of PAD by Combined Transplantation of BMCs
Official title: Transplantation of Autologous Mononuclear Bone Marrow Stem Cells in Patients With Peripheral Arterial Disease (TAM-PAD Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Keywords: stem cell therapy
peripheral arterial disease
limb ischemia
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2006-12-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in patients with PAD. BMCs were transplanted into the ischemic limb.

After 2 and 13 months walking distance and perfusion indices were monitored.


Eligibility criteria: Inclusion Criteria:

* severe limb ischemia

Exclusion Criteria:

* infectious disease
* cancer

Primary outcomes:
measure: ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography
Secondary outcomes:
measure: feasibility
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-University
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Bodo E Strauer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01273740: Swedish External Support Study
Official title: Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Keywords: PTFE bypass
femoro-popliteal
femoro-crural
popliteal arteries
crural arteries
external support
crtical limb ischemia
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Lasarettet Boden
name: Borås Lasarett
name: Eskilstuna Lasarettet
name: Falu Lasarett Röntgen
name: Department of Surgery, Sahlgrenska sjukhuset, Göteborg
name: Department of Surgery, Östra sjukhuset, Göteborg
name: Lasarett Gävle
name: Helsingborgs Hospital
name: Kalmar County Hospital
name: Karlstad Central Hospital
name: Kristiansund Hospital
name: Lund University Hospital
name: Malmö University
name: Department of Surgery, Lasarettet, Motala
name: Department of Surgery, Lasarettet, Mölndal
name: Department of Surgery, Lasarettet, Norrköping
name: Department of Surgery, Lasarettet, Nyköping
name: Department of Surgery, Lasarettet, Skellefteå
name: Department of Surgery, Kärnsjukhuset, Skövde
name: Department of Surgery, S:t Görans Sjukhus, Stockholm
name: Department of Surgery, Södersjukhuset, Stockholm
name: Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg
name: Uppsala University Hospital
name: Västervik Hospital
name: Region Västmanland
name: Department of Surgery, Lasarettet, Växjö
name: Department of Surgery, Lasarettet, Örebro
name: Department of Surgery, Lasarettet, Östersund
First posted: 2011-01-10
Enrollment: 334
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study to evaluate the effect of adding external support to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.


Eligibility criteria: Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Primary outcomes:
measure: primary graft patency
Secondary outcomes:
measure: limb salvage
Other outcomes:
Locations:
Study officials:
affiliation: Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
name: Fredrik BG Lundgren, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04154540: Posturography-Neuropathy
Official title: Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathy Demyelinating
Keywords: Gait
Balance
Posture
Charcot-Marie-Tooth
Chronic inflammatory demyelinating polyneuropathy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.


Eligibility criteria: Inclusion Criteria:

* CMT1A for molecular-proven Group 1 (PMP22 duplication)
* IPDC likely or defined for Group 2
* Able to walk 10 m unassisted

Exclusion Criteria:

* Neurological history other than neuropathy: epilepsy, stroke, dementia
* Pregnant women
* Person under guardianship or trusteeship
* Musculoskeletal conditions other than neuropathy impairing walking abilities
* Major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)

Primary outcomes:
measure: Posturography (Romberg's quotient)
timeFrame: Time 0 ; single session
Secondary outcomes:
measure: The Timed Up and Go test (TUG)
timeFrame: Time 0 ; single session
measure: stride length (in millimeters) parameters
timeFrame: Time 0 ; single session
measure: stride time (in seconde) parameters
timeFrame: Time 0 ; single session
measure: velocity (meter/seconde) parameters
timeFrame: Time 0 ; single session
measure: cadence (step/min) parameters
timeFrame: Time 0 ; single session
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Céline TARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00450840: Simvastatin in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Septic Shock
Keywords: septic shock
simvastatin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-03-22
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 beneficial effect of statins to prevent cardiovascular events in patients at risk is well established. Recent trials demonstrated that statins can exert a number of vascular actions independent of lipid lowering. Short-term simvastatin therapy recently has been reported to reduce mortality in 2 different animal models of sepsis. Pleiner and coworkers could demonstrate potent vasoprotective properties of simvastatin during Escherichia coli endotoxin induced endotoxemia in healthy volunteers. In a population-based cohort analysis it was demonstrated that administration of statins was associated with a reduced risk of subsequent sepsis. Thus, simvastatin treatment may offer a new therapeutic strategy for clinical conditions associated with inflammation like severe sepsis and septic shock. The aim of the present study is to test the hypothesis that short term treatment with simvastatin may mitigate the detrimental vascular effects of acute inflammation in patients admitted to the intensive care unit requiring treatment for septic shock.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Septic Shock for less than 48 hours

Exclusion Criteria:

* Pregnancy
* Unable to receive enteral medications
* Expected survival of less than 72 hours
* Treatment in the previous 3 weeks with simvastatin or other HMG-CoA reductase inhibitors
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History of known or suspected porphyria
* High risk of rhabdomyolysis (multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) ≥ten-times upper limit of normal
* Hemorrhagic shock

Primary outcomes:
measure: Time to shock reversal as defined by cessation of vasopressor support > 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dep. of Internal Medicine III
Study officials:
affiliation: Medical University of Vienna, Intensive Care Unit
name: Peter Schenk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobesh PP, Olsen KM. Statins role in the prevention and treatment of sepsis. Pharmacol Res. 2014 Oct;88:31-40. doi: 10.1016/j.phrs.2014.04.010. Epub 2014 May 2.
Clinical trial NCT05366140: Thoracic-Lumbar Arthrodesis- Implanet Jazz
Official title: Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spondylolisthesis
Spinal Stenosis
Degenerative Disease
Keywords: Thoracic-Lumbar Arthrodesis
Spinal fusion
back pain
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Implanet America, Inc.
First posted: 2022-05-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men and women of any/all ethnic groups who are appropriate candidates for hybrid thoracolumbar fixation and will receive the Implanet Jazz System (TM) during their arthrodesis surgery.

Brief summary: Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Detailed description: To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' patients who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation.

Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, 18 years of age and older
* Qualified candidate for hybrid thoracolumbar fixation with the Implanet Jazz System TM during arthrodesis surgery.

Exclusion Criteria:

* Individuals who have not yet reached the age of 18.

Primary outcomes:
measure: clinical prospective review- Prospective Database study for future studies
timeFrame: 5- years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT00604240: Telephone Follow-up From an Intensive Care Nursery
Official title: Telephone Follow-up From an Intensive Care Nursery: What do Parents Actually Remember?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Information Retention
Keywords: NICU
caregivers
discharge instructions
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2008-01-30
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents/caregivers of infants who are hospitalized in the NICU

Brief summary: The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult transition time for caregivers of a previously hospitalized infant. To help ease this stressful period, doctors and nurses give caregivers a large amount of information prior to their infant leaving the NCIU. How much caregivers remember about medications, follow-up appointments, and general well-child care has not been studied. Caregivers who choose to participate will receive a phone call 2-7 days after discharge where they will be asked questions pertaining to the information that was discussed with them at the time of discharge. The purpose of the study is to determine how much information caregivers retain after leaving the NICU.


Eligibility criteria: Inclusion Criteria:

* Parents/caregivers of infants who have spent one week or longer in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.

Exclusion Criteria:

* Parents / caregivers of infants who have spent less than one week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.

Primary outcomes:
measure: Amount of information that parents / caregivers are able to retain
timeFrame: Within one week after the infant is discharged from the NICU
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Christiana Hospital and Thomas Jefferson University Hospital
name: Constance Andrejko, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819740: Analysis of a New Biomarker for Prostate Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Suspected Prostate Cancer
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 28
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with clinical or laboratory suspected of prostate cancer attends in Parc Tauli Universitary Hospital.

Brief summary: The aim of our study is to determine if the levels of the "HEM" substance in seminal plasma are associated with the presence of prostate cancer in transrectal prostate biopsy.


Eligibility criteria: Inclusion Criteria:

* Clinical or laboratory suspected of prostate cancer

Exclusion Criteria:

* Inability to ejaculate

Primary outcomes:
measure: substance "HEM" concentration in seminal plasma (mEq/L measured by spectro-photometry
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Taulí
state: Barcelona
Study officials:
affiliation: Hospital Universitario Parc Tauli de Sabadell. Spain
name: Miriam Barrio-Muñoz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03347240: Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
Official title: Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Dystonia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The disability inflected by dystonia encouraged the development of many neurosurgical procedures.

This is a prospective study included 120 patients suffering from intractable secondary dystonia.

They were subjected to different neurosurgical treatments and were assessed through the follow up period

Detailed description: Background:

Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. The disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients.

The aim of this study was to compare the outcomes of different Neuroablative and modulation techniques in treatment of secondary dystonia.

Patients and methods This is a prospective study included 120 patients suffering from intractable secondary dystonia. Ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal dystonia were included in the Botulinum toxin injection group. Patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (CAPR) or the (ITB) groups.

Assessment measures included the evaluation of the muscle tone, range of motion, and the Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.

Eligibility criteria: Inclusion Criteria:

* secondary dystonia of previous etiologies

Exclusion Criteria:

* patients who are not candidate for anaesthesia

Primary outcomes:
measure: Burke-Fahn-Marsden dystonia rating scale
timeFrame: 1 year
Secondary outcomes:
measure: Modified Ashworth scale
timeFrame: 1 year
measure: Barthel index
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Associate professor
name: Walid A Abdel Ghany, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03761940: Health Status of Women With Breast Cancer
Official title: An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Women With Early Breast Cancer
Breast Conserving Surgery
Radiotherapy
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who satisfy the inclusion exclusion criteria can be selected either from clinic notes, MDT records, or at clinic.

Brief summary: The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost utility analysis, QALY data is required. This can either be collected within trial or published data can be used.

In the United Kingdom (UK) there is no up to date QALY data for women with early breast cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to date QALY data for women in this cohort.


Eligibility criteria: Inclusion Criteria:

* Female
* Over 18 year of age
* Has had breast cancer, treated with both breast conserving surgery and radiotherapy.
* Is willing to complete an EQ5D and a demographic questionnaire.

Exclusion Criteria:

* Does not speak sufficiently to complete a study questionnaires.
* Has not already been approached to complete an OSTaRa questionnaire.

Primary outcomes:
measure: Questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
state: Wiltshire
Study officials:
References:
Clinical trial NCT04353440: Association Between Sagittal Patellar Offset and Anterior Knee Pain in Total Knee Arthroplasty
Official title: Association Between Sagittal Patellar Offset and Anterior Knee Pain After Multiradius Total Knee Replacement.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Gonarthrosis, Bilateral
Knee Osteoarthritis
Knee Arthritis
Keywords: total knee arthroplasty
anterior knee pain
sagittal patellar offset
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing total knee arthroplasty due to severe gonarthrosis

Brief summary: The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.

Detailed description: A prospective, observational study. A total of to 80 subjects requiring bilateral multiradius knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain.In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"\[1\]. Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Eligibility criteria: Inclusion Criteria:

* Patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement

Exclusion Criteria:

* Patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel

Primary outcomes:
measure: anterior patellar offset ratio
timeFrame: minimum 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Scott CEH, Clement ND, Yapp LZ, MacDonald DJ, Patton JT, Burnett R. Association Between Femoral Component Sagittal Positioning and Anterior Knee Pain in Total Knee Arthroplasty: A 10-Year Case-Control Follow-up Study of a Cruciate-Retaining Single-Radius Design. J Bone Joint Surg Am. 2019 Sep 4;101(17):1575-1585. doi: 10.2106/JBJS.18.01096.