louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02813512: Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Official title: Adipose-Derived Stem Cells (ADSCs) Injections for Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects who have chronic non-hemorrhagic stroke (\>6 months).

Detailed description: This open-label clinical trial will compare outcomes of subjects with chronic stroke. Six subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and eight standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), ( Barthel Index )、 ( Berg balance scale )、 (Fugl - Meyer test )、(Action research arm test )、 (Purdue pegboard )、 ( grip strength measurement ) 、(somatosensory evoked potential, SSEP) at 1 month, 3 months, and 6 months after treatment.

Eligibility criteria: Inclusion Criteria:

* stroke investigators with age 65 to 80 years
* history of stroke between six months and 10 years
* Systolic pressure and Diastolic pressure were maintained under 160 mmHg and 110 mmHg
* INR \< 2.5, platelets counts 1-5 x 10\^5/μl
* Damaged area range between 0.5 cm to 6 cm by brain MRI

Exclusion Criteria:

* Pregnant women
* Investigators with AIDS, cancer, liver dysfunction
* Others can't fit into the trial evaluate by investigator

Primary outcomes:
measure: Neurological function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Gwo Xi Stem Cell Applied Technology Co., Ltd.
city: Hualien city
country: Taiwan
facility: Hualien Tzu Chi Hospital
Study officials:
affiliation: Hualien Tzu Chi General Hospital
name: Hualien T Hospital
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiu TL, Baskaran R, Tsai ST, Huang CY, Chuang MH, Syu WS, Harn HJ, Lin YC, Chen CH, Huang PC, Wang YF, Chuang CH, Lin PC, Lin SZ. Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study. J Tissue Eng Regen Med. 2022 Jan;16(1):3-13. doi: 10.1002/term.3256. Epub 2021 Oct 21.
Clinical trial NCT01923012: Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
Official title: Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carotid Disease
Atherosclerosis
Lead sponsor: Azienda Ospedaliera Sant'Anna
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.


Eligibility criteria: Inclusion Criteria:

* carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque

Exclusion Criteria:

* renal and/or hepatic failure
* diseases with secondary calcifications
* dementia
* previous strokes
* concomitant use of anticoagulants
* concomitant infections
* pregnancy or breastfeeding
* reduced patient's compliance

Primary outcomes:
measure: Percentage reduction in plaque calcification and carotid stenosis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04192812: PREOPERATIVE GONADOTROPINE-RELEASING HORMONE AGONIST THERAPY BEFORE SURGERY FOR UTERİN FIBROIDS
Official title: THE EFFICACY OF PREOPERATIVE USAGE OF GONADOTROPINE-RELEASING HORMONE AGONIST IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Fibroid
Gonadotropin-Releasing Hormone-Dependent Precocious Puberty
Lead sponsor: Alkü Alanya Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: PROSPECTİVE RANDOMİSED CONTROLLED TRİAL
Primary purpose: TREATMENT

Brief summary: Uterin fibroids are the most common operation indication for hysterectomy. Dyring laparoscopic hysterectomy the amount of bleeding is a great difficulty.There are a lot of clinical researchs to reduce the haemorrhage during open hysterectomy but not laparoscopic procedure. In ALKU ERH clinic, researchers decided to smaller the size of fibroid by using GnRH analogues before total laparoscopic hysterectomy to reduce the haemorrhage amount.

Detailed description: After randomising patients to two groups, one of the group will be controle group and the other group will be working group and researchers decided to use 3,75 mg leuprolide acetate as GnRHa subcutanously in every four week, throughout 3 months before surgery to the working group, researchers will record intraoperative amount of bleeding by measuring the blood in suction scale, the duration of surgery, difference between preoperative haemoglobin levels and uterin weight. researchers will comparise all theese parameters ibn to two groups.

Eligibility criteria: Inclusion Criteria:

* MYOMA UTERI
* APPROPİATE FOR LAPAROSCOPY

Exclusion Criteria:

* MALİGNANCY

Primary outcomes:
measure: AMOUNT OF BLEEDİNG
timeFrame: 0 minute - 180 minute
measure: DURATION AF SURGERY
timeFrame: 0 MINUTE- 180 MINUTE
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alku Alanya Education and Research Hospital
Study officials:
affiliation: ALKU EDUCATİON AND RESEARCH HOSPITAL
name: MERAL TUĞBA ÇİMŞİR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01488812: Waiting Time to Operation for Hip-fracture Patients
Official title: Waiting Time to Operation for Hip-fracture Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip-fracture
Keywords: Hip-fracture
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 576
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hip fracture patients admitted to Danderyd Hospital Orthopaedic Department from 1st June 2007 to 1st June 2008

Brief summary: This study investigates the relationship between waiting time to surgery and the risk for medical complications and 1-year mortality in hip-fracture patients.


Eligibility criteria: Inclusion Criteria:

* Hip-fracture patient

Exclusion Criteria:

* Periprosthetic fracture
* Pathological fracture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Danderyd Hospital, Stockholm, Sweden
name: Olof Skoldenberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830712: A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors
Official title: A Long-Term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors. A Retrospective Follow-up Assessment to F7HAEM/USA/3/USA and F7HAEM/USA/4/USA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).

Brief summary: This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.


Eligibility criteria: Inclusion Criteria:

* Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)

Primary outcomes:
measure: Long-term changes in general mobility/ambulation/activity
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
Secondary outcomes:
measure: Long-term changes in work/school attendance
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
measure: Long-term changes in employment status
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
measure: Long-term changes in body mass index (BMI)
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
measure: Long-term changes in complications related to surgical procedure and/or prostheses
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
measure: Overall frequency of bleeding episodes
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
measure: Number of joint infections
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
measure: Number of treatment types (on demand, prophylaxis)
timeFrame: From pre-operative (baseline) functional status and up to at least 5 years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01904812: Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.


Eligibility criteria: Inclusion Criteria:

* - Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.
* Patients able to understand written and spoken French.
* Patients aged from 18 to 75 years
* Patients who have received written and oral information about the research.

Exclusion Criteria:

* - Patients aged less than 18 years
* Patients aged more than 75 years
* Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible

Primary outcomes:
measure: data for quality of life and satisfaction
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 months
Secondary outcomes:
measure: Clinical data
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
affiliation: CHU Dijon - Department of Internal Medicine and Systemic Diseases
name: Jean-François BESANCENOT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.
Clinical trial NCT04031612: Neoadjuvant Database
Official title: Prospective and Retrospective Neoadjuvant Breast Cancer Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoadjuvant Treatment in Breast Cancer
Keywords: Cancer; Breast, Neoadjuvant
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non metastatic breast cancer who received neoadjuvant chemotherapy prior to tumor surgery.

Brief summary: The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way.

This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.


Eligibility criteria: Inclusion Criteria:

* Women followed for breast cancer in Georges Francois Leclerc Center
* Neoadjuvant chemotherapy
* Age \>= 18

Exclusion Criteria:

* Males
* Metastatic breast cancer

Primary outcomes:
measure: Patient survival
timeFrame: 5 years
Secondary outcomes:
measure: Collection of patient and treatment characteristics
timeFrame: 5 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Methodology, Biostatistics and Data Management Unit
Study officials:
References:
Clinical trial NCT00545012: A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures
Official title: A 30-month Safety and Efficacy Follow-up Study With Levetiracetam at Individualized Optimal Dose in Children (4-17 Years Old at Inclusion) Suffering From Typical Absences in Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Absence Seizures
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 4
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.


Eligibility criteria: Inclusion Criteria:

* Male/female 4-17 years old having participated in study N162 or in study N163
* suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
* expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration

Exclusion Criteria:

* allergy/intolerance to pyrrolidine derivatives and/or excipients
* use of \> 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine

Primary outcomes:
measure: Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04649112: Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies
Official title: A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CD19 Expressing Malignancies
Hematologic Malignancy
Lead sponsor: Precision BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory CD19+ expressing malignancies
* At least 2 prior regimens per Standard of Care

Exclusion Criteria:

* No history of active CNS involvement

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Day 1 - Day 28
measure: Number of participants with Dose Limiting Toxicity(ies)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MDA
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Precision BioSciences, Inc.
name: Monika Vainorius, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00797212: A New Glucose Meter With Alternative Site Testing
Official title: Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).

Detailed description: The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.

Eligibility criteria: Inclusion Criteria:

* Have type 1 or type 2 diabetes
* Be \>18\<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age
* Be willing to complete all study procedures
* Be routinely testing their blood sugar at home (at least once per day)
* Be able to speak, read, and understand English and understand the Informed Consent document
* Be able to read the labeling instructions

Exclusion Criteria:

* Minors \<18 years of age and adults \>75 years of age
* Pregnancy
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
* Disorders in the fingertip lancing areas
* Acute or chronic infections, particularly skin infections
* Infection with a blood borne pathogen
* Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion.
* Hemophilia or any other bleeding disorder
* Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
* Working for a competitive medical device company

Primary outcomes:
measure: Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
timeFrame: One hour
Secondary outcomes:
measure: Percentage of Participants Rated as <=3 (Labeling Comprehension)
timeFrame: One hour
measure: Percentage of Participant Ratings for Overall Testing Experience With This Meter
timeFrame: One hour
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
Study officials:
affiliation: Jasper Clinic, Inc.
name: Vimala Sethy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: